Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System
Study Details
Study Description
Brief Summary
The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group).
150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Ovation™ Abdominal Stent Graft System Implant of Ovation™ Abdominal Stent Graft System |
Device: Ovation™ Abdominal Stent Graft System
Implant of Ovation™ Abdominal Stent Graft System
|
Outcome Measures
Primary Outcome Measures
- The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure. [30 days]
Major adverse events (MAE) are defined as any one of the following events: Death Myocardial Infarction Stroke (excludes TIA) Renal Failure (excludes renal insufficiency) Respiratory Failure (excludes COPD or pulmonary complications) Paralysis (excludes paraparesis) Bowel Ischemia Procedural Blood Loss (≥1,000 cc)
- The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success. [1 year]
Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs. Freedom from Type I & III endoleaks at 12 months Freedom from stent graft migration at 12 months Freedom from abdominal aortic aneurysm (AAA) enlargement at 12 months Freedom from abdominal aortic aneurysm (AAA) rupture and conversion to open repair through 12 months Endoleak Definition: Type I - Ineffective seal at either the proximal or distal sealing zones Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration Type IV - Blood flow through an intact fabric.
Eligibility Criteria
Criteria
Inclusion/Exclusion Criteria:
Inclusion Criteria
All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
-
Patient is > 18 years of age
-
Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
-
Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form
-
Patient is considered by the treating physician to be a candidate for elective open surgical repair of the abdominal aortic aneurysm (AAA) (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification. ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.
-
Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
-
Abdominal aortic aneurysm ≥5.0 cm in diameter
-
Aneurysm has increased in size by 0.5 cm in last 6 months.
-
Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
-
Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Stent Graft System.
-
Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
-
Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
-
Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
-
Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm.
-
Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 13 cm.
-
Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥10 mm and ≤ 45º if proximal neck is <10 mm.
-
Patient must be willing to comply with all required follow-up exams.
Exclusion Criteria
Patients that meet ANY of the following are not eligible for enrollment into the study:
-
Patient has a dissecting aneurysm
-
Patient has an acutely ruptured aneurysm
-
Patient has an acute vascular injury
-
Patient has a need for emergent surgery
-
Patient has a known thoracic aortic aneurysm or dissection.
-
Patient has a mycotic aneurysm or has an active systemic infection
-
Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
-
Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
-
Patient has a major surgical or interventional procedure planned ≤30 days of the AAA repair.
-
Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
-
Patient has history of bleeding disorders or refuses blood transfusions.
-
Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl
-
Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
-
Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.
-
Patient has a body habitus that would inhibit X-ray visualization of the aorta
-
Patient has a limited life expectancy of less than 1 year
-
Patient is currently participating in another investigational device or drug clinical trial
-
Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Community Care Physicians | Latham | New York | United States | 12110 |
Sponsors and Collaborators
- TriVascular, Inc.
Investigators
- Principal Investigator: Manish Mehta, MD, Albany Medical College
Study Documents (Full-Text)
More Information
Additional Information:
- TriVascular Website
- Journal of Vascular Surgery® Publishes Results of the TriVascular Ovation™ Global Pivotal Study
Publications
None provided.- 771-0006
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Ovation™ Abdominal Stent Graft System |
---|---|
Arm/Group Description | Implant of Ovation™ Abdominal Stent Graft System Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System |
Period Title: Index Procedure to 1 Month | |
STARTED | 161 |
COMPLETED | 160 |
NOT COMPLETED | 1 |
Period Title: Index Procedure to 1 Month | |
STARTED | 160 |
COMPLETED | 157 |
NOT COMPLETED | 3 |
Period Title: Index Procedure to 1 Month | |
STARTED | 157 |
COMPLETED | 152 |
NOT COMPLETED | 5 |
Period Title: Index Procedure to 1 Month | |
STARTED | 152 |
COMPLETED | 138 |
NOT COMPLETED | 14 |
Period Title: Index Procedure to 1 Month | |
STARTED | 138 |
COMPLETED | 128 |
NOT COMPLETED | 10 |
Period Title: Index Procedure to 1 Month | |
STARTED | 128 |
COMPLETED | 109 |
NOT COMPLETED | 19 |
Period Title: Index Procedure to 1 Month | |
STARTED | 109 |
COMPLETED | 93 |
NOT COMPLETED | 16 |
Baseline Characteristics
Arm/Group Title | Ovation™ Abdominal Stent Graft System |
---|---|
Arm/Group Description | Implant of Ovation™ Abdominal Stent Graft System Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System |
Overall Participants | 161 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
73
(8)
|
Sex: Female, Male (Count of Participants) | |
Female |
20
12.4%
|
Male |
141
87.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
15
9.3%
|
Not Hispanic or Latino |
144
89.4%
|
Unknown or Not Reported |
2
1.2%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
4
2.5%
|
White |
149
92.5%
|
More than one race |
0
0%
|
Unknown or Not Reported |
8
5%
|
Region of Enrollment (participants) [Number] | |
United States |
111
68.9%
|
Germany |
30
18.6%
|
Chile |
20
12.4%
|
American Society of Anesthesiology (ASA) Grade (Count of Participants) | |
ASA Grade I |
9
5.6%
|
ASA Grade II |
45
28%
|
ASA Grade III |
96
59.6%
|
ASA Grade IV |
11
6.8%
|
Cardiovascular Disease (Count of Participants) | |
Coronary artery disease |
72
44.7%
|
Valvular heart disease |
19
11.8%
|
Angina |
11
6.8%
|
Cardiomyopathy |
11
6.8%
|
Congestive Heart Failure |
12
7.5%
|
Myocardial infarction |
33
20.5%
|
Arrhythmia |
35
21.7%
|
Hypertension |
136
84.5%
|
Hypotension |
1
0.6%
|
Hyperlipidemia |
113
70.2%
|
Peripheral Vascular Disease, Stroke and Aneurysm History (Count of Participants) | |
Peripheral vascular disease |
38
23.6%
|
Carotid artery disease |
21
13%
|
Transient ischemic attack |
8
5%
|
Stroke (CVA) |
13
8.1%
|
Family History of aneurysms |
10
6.2%
|
Pulmonary History (Count of Participants) | |
Smoking |
113
70.2%
|
Chronic obstructive pulmonary disease (COPD) |
44
27.3%
|
Gastrointestinal, Genitourinary, Reproductive History (Count of Participants) | |
Renal failure/insufficiency |
22
13.7%
|
Diabetes |
34
21.1%
|
Alcohol abuse |
3
1.9%
|
Hematological Problems (hemorrhage, coagulopathy disorder, anemia, platelet disorder) (Count of Participants) | |
Count of Participants [Participants] |
12
7.5%
|
Other Significant Medical Condition (Count of Participants) | |
Count of Participants [Participants] |
122
75.8%
|
Proximal Aorta (mm) [Mean (Standard Deviation) ] | |
Aortic diameter 35 mm proximal to proximal renal artery |
25.0
(2.7)
|
Aortic diameter at distal renal artery |
22.5
(2.7)
|
Aortic diameter 7 mm distal to distal renal artery |
22.1
(2.9)
|
Aortic diameter 13 mm distal to distal renal artery |
22.7
(3.1)
|
Proximal neck length |
23.0
(12.5)
|
Proximal Aorta-Juxtarenal angle (Degrees) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Degrees] |
19.1
(13.5)
|
Aortic Aneurysm-Aortic aneurysm diameter (mm) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [mm] |
53.6
(9.0)
|
Aortic aneurysm diameter distribution (Count of Participants) | |
40.0mm-49.9mm |
57
35.4%
|
50.0mm-59.9mm |
81
50.3%
|
60.0mm-69.9mm |
14
8.7%
|
70.0mm-79.9mm |
5
3.1%
|
80.0mm-89.9mm |
2
1.2%
|
90.0mm-99.9mm |
2
1.2%
|
Distal Aorta (mm) [Mean (Standard Deviation) ] | |
Aortic bifurcation diameter |
20.3
(6.9)
|
Left iliac diameter |
13.7
(3.3)
|
Left iliac minimum access diameter |
7.0
(1.6)
|
Right iliac diameter |
13.9
(3.0)
|
Right iliac minimum access diameter |
7.0
(1.6)
|
Outcome Measures
Title | The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure. |
---|---|
Description | Major adverse events (MAE) are defined as any one of the following events: Death Myocardial Infarction Stroke (excludes TIA) Renal Failure (excludes renal insufficiency) Respiratory Failure (excludes COPD or pulmonary complications) Paralysis (excludes paraparesis) Bowel Ischemia Procedural Blood Loss (≥1,000 cc) |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ovation™ Abdominal Stent Graft System |
---|---|
Arm/Group Description | Implant of Ovation™ Abdominal Stent Graft System Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System |
Measure Participants | 161 |
Count of Participants [Participants] |
4
2.5%
|
Title | The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success. |
---|---|
Description | Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs. Freedom from Type I & III endoleaks at 12 months Freedom from stent graft migration at 12 months Freedom from abdominal aortic aneurysm (AAA) enlargement at 12 months Freedom from abdominal aortic aneurysm (AAA) rupture and conversion to open repair through 12 months Endoleak Definition: Type I - Ineffective seal at either the proximal or distal sealing zones Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration Type IV - Blood flow through an intact fabric. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
138 subjects completed study through 1 year |
Arm/Group Title | Ovation™ Abdominal Stent Graft System |
---|---|
Arm/Group Description | Implant of Ovation™ Abdominal Stent Graft System Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System |
Measure Participants | 138 |
Count of Participants [Participants] |
137
85.1%
|
Adverse Events
Time Frame | 5 years | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Ovation™ Abdominal Stent Graft System | |
Arm/Group Description | Implant of Ovation™ Abdominal Stent Graft System Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System | |
All Cause Mortality |
||
Ovation™ Abdominal Stent Graft System | ||
Affected / at Risk (%) | # Events | |
Total | 35/161 (21.7%) | |
Serious Adverse Events |
||
Ovation™ Abdominal Stent Graft System | ||
Affected / at Risk (%) | # Events | |
Total | 129/161 (80.1%) | |
Blood and lymphatic system disorders | ||
Hematoma | 4/161 (2.5%) | |
Post-procedureal Bleeding | 4/161 (2.5%) | |
Acute Blood Loss | 1/161 (0.6%) | |
Anemia | 1/161 (0.6%) | |
Disseminated Intravascular Coagulation with Septic Shock | 1/161 (0.6%) | |
Disseminated Intravascular Coagulation | 1/161 (0.6%) | |
Elevated White Blood Cells | 1/161 (0.6%) | |
Heparin Induced Thrombocytopenia | 1/161 (0.6%) | |
Lymphatic leak | 1/161 (0.6%) | |
Neutropenia | 1/161 (0.6%) | |
Polycythaemia Vera | 1/161 (0.6%) | |
Severe Anemia Secondary To Myelodisplasia | 1/161 (0.6%) | |
Subararchnoidal Bleeding | 1/161 (0.6%) | |
Cardiac disorders | ||
Angina | 6/161 (3.7%) | |
Arrhythmia | 7/161 (4.3%) | |
Congestive Heart Failure | 10/161 (6.2%) | |
Hypertension | 1/161 (0.6%) | |
Hypotension | 3/161 (1.9%) | |
Myocardial Infarction | 6/161 (3.7%) | |
Atrial fibrillation with RVR | 1/161 (0.6%) | |
Atrial fibrillation With Rapid Ventricular Response | 1/161 (0.6%) | |
Aortic Valve Stenosis | 3/161 (1.9%) | |
Cardiac Arrest | 2/161 (1.2%) | |
Cardiogenic Shock | 1/161 (0.6%) | |
Coronary Artery Disease: Chest Pain, Le Edema, Ruq Abdominal Pain | 1/161 (0.6%) | |
Mitral Reguritation | 1/161 (0.6%) | |
Severe Aortic Stenosis | 1/161 (0.6%) | |
Sinoatrial Node Dysfunction | 1/161 (0.6%) | |
Tachycardia | 1/161 (0.6%) | |
Tricuspid Regurgitation | 1/161 (0.6%) | |
Unstable Angina | 1/161 (0.6%) | |
Worsening Atrial Fibrillation | 2/161 (1.2%) | |
Worsening Chronic Heart Disease | 1/161 (0.6%) | |
Worsening Congestive Heart Failure | 1/161 (0.6%) | |
Endocrine disorders | ||
Thyreoidectomy | 1/161 (0.6%) | |
Eye disorders | ||
Circulatory Disorder Left Eye | 1/161 (0.6%) | |
Surgical Procedure: pars-Plana Vitrectomy, Cerclage and Kryocoagulation right Eye | 1/161 (0.6%) | |
Gastrointestinal disorders | ||
Adynamic ileus | 1/161 (0.6%) | |
Bowel ischemia | 1/161 (0.6%) | |
Bowel obstruction | 1/161 (0.6%) | |
Infection (other than wound) | 8/161 (5%) | |
Acute On Chronic Pancreatitis | 1/161 (0.6%) | |
Air in Intestine | 1/161 (0.6%) | |
Bleeding Duodenal Ulcer | 1/161 (0.6%) | |
Bloody Stools | 1/161 (0.6%) | |
Bowel Perforation | 1/161 (0.6%) | |
Cholecystitis | 2/161 (1.2%) | |
Choledocholithiasis | 1/161 (0.6%) | |
Cholelithiasis | 1/161 (0.6%) | |
Dilated Biliary Ducts | 1/161 (0.6%) | |
Diverticulitis | 1/161 (0.6%) | |
Duodenal Angiodysplasia | 1/161 (0.6%) | |
Esophagitis | 1/161 (0.6%) | |
Gastrointenstinal Bleed | 5/161 (3.1%) | |
Hematochezia | 1/161 (0.6%) | |
Hemorrhoids With Hematochezia | 1/161 (0.6%) | |
Ischemic Colitis | 1/161 (0.6%) | |
Nausea W/ Vomiting | 1/161 (0.6%) | |
Urinary Retention | 3/161 (1.9%) | |
Fever | 2/161 (1.2%) | |
General disorders | ||
Bilateral Leg Weakness | 1/161 (0.6%) | |
Chest Pain | 1/161 (0.6%) | |
Chest Tightness/Non-Cardiac Chest Pain | 2/161 (1.2%) | |
Collapse | 1/161 (0.6%) | |
Death | 1/161 (0.6%) | |
Death from unknown cause | 2/161 (1.2%) | |
Dizziness | 1/161 (0.6%) | |
Epigastric/Substernal Pain | 1/161 (0.6%) | |
Groin Pain | 1/161 (0.6%) | |
Groin Pain Inguinal Hernia | 1/161 (0.6%) | |
Leg Pain | 1/161 (0.6%) | |
Lightheaded | 1/161 (0.6%) | |
Lower Extremity Edema | 1/161 (0.6%) | |
Lumbar And Right Lower Extremity Severe Pain | 1/161 (0.6%) | |
Near Syncope/Weakness | 1/161 (0.6%) | |
Necrosis | 1/161 (0.6%) | |
Right Lower Extremity Significant Swelling W/Edema | 1/161 (0.6%) | |
Right Upper Quadrant Pain | 1/161 (0.6%) | |
Syncope | 3/161 (1.9%) | |
Abdominal and Chest Pain | 1/161 (0.6%) | |
Syncope Related To Blood Loss From Chest Wall Hematoma | 1/161 (0.6%) | |
Unknown at this time- awaiting hospital records | 1/161 (0.6%) | |
Worsening Claudication | 1/161 (0.6%) | |
Worsening Lower Back And Leg Pain | 1/161 (0.6%) | |
Immune system disorders | ||
Anaphylactic Shock | 1/161 (0.6%) | |
Anaphylaxis | 1/161 (0.6%) | |
Infections and infestations | ||
Abdominal Sepsis | 1/161 (0.6%) | |
Acute Pyelonephritis | 1/161 (0.6%) | |
C-Diff Infection | 1/161 (0.6%) | |
Erysipel | 1/161 (0.6%) | |
Fungal Infection In Groin | 1/161 (0.6%) | |
Herpes Zoster, Left Lumbar Pain And Echymosis | 1/161 (0.6%) | |
Lower Respiratory Tract Infection | 1/161 (0.6%) | |
Pneumonia-MRSA | 1/161 (0.6%) | |
Respiratory Infection | 1/161 (0.6%) | |
Sepsis | 1/161 (0.6%) | |
Septic Right Knee Joint | 1/161 (0.6%) | |
Septic Shock | 1/161 (0.6%) | |
Spontaneous Bacterial Peritonitis | 1/161 (0.6%) | |
Urinary Tract Infection By Hydronephrosis | 1/161 (0.6%) | |
Viral Encephalopathy | 1/161 (0.6%) | |
Wound Infection | 1/161 (0.6%) | |
Metabolism and nutrition disorders | ||
Dehydration | 1/161 (0.6%) | |
Hypoglycemia | 2/161 (1.2%) | |
Hyponatremia | 1/161 (0.6%) | |
Lactic Acidosis With Liver Failure | 1/161 (0.6%) | |
Severe Hyponatremia | 1/161 (0.6%) | |
Groin Hernia | 1/161 (0.6%) | |
Musculoskeletal and connective tissue disorders | ||
Broken Shoulder | 1/161 (0.6%) | |
Effusion of the left hip | 1/161 (0.6%) | |
Fall-fx R prox humerous | 1/161 (0.6%) | |
Fracture right hip | 2/161 (1.2%) | |
Hip fracture | 1/161 (0.6%) | |
J1 DJD L hip | 1/161 (0.6%) | |
L1 Compression Fracture | 1/161 (0.6%) | |
Left hip fracture | 1/161 (0.6%) | |
Left knee arthroplasty | 1/161 (0.6%) | |
R Knee Arthroplasty | 1/161 (0.6%) | |
R Knee spacer removal | 1/161 (0.6%) | |
Right femur fracture | 1/161 (0.6%) | |
Acute Gout Left Knee | 1/161 (0.6%) | |
Acute Gouty Arthritis | 1/161 (0.6%) | |
Acute Onset Of Chronic Polyarthitis | 1/161 (0.6%) | |
Costochondritis | 1/161 (0.6%) | |
Gait Weakness/Progressive Decline | 1/161 (0.6%) | |
Hernia | 1/161 (0.6%) | |
Incarcerated L Inguinal Hernia | 2/161 (1.2%) | |
Incarcerated Left Inguinal Hernia With Secondary small bowel obstruction | 1/161 (0.6%) | |
Rupture Tendons Right Shoulder. Arthroscopic Repair | 1/161 (0.6%) | |
artificial Knee joint | 1/161 (0.6%) | |
back pain | 2/161 (1.2%) | |
endoprothesis of right knee | 1/161 (0.6%) | |
enstage cuff tear arthrop | 1/161 (0.6%) | |
fractured left hip | 1/161 (0.6%) | |
hip-tep surgery right | 1/161 (0.6%) | |
hip/back pain | 1/161 (0.6%) | |
impingement-syndrome | 1/161 (0.6%) | |
lumbal spinal stenosis | 1/161 (0.6%) | |
Osteoarthritis, right hip | 1/161 (0.6%) | |
Pain left knee | 1/161 (0.6%) | |
Quadricept tendon rupture | 1/161 (0.6%) | |
Right knee revision | 1/161 (0.6%) | |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Bladder | 3/161 (1.9%) | |
Bladder Carcinoma | 1/161 (0.6%) | |
Colon | 1/161 (0.6%) | |
Lung | 1/161 (0.6%) | |
Mass In Liver | 1/161 (0.6%) | |
Metastic Adenocarcinoma | 1/161 (0.6%) | |
Multiple Myeloma | 2/161 (1.2%) | |
Nasal Skin Cancer | 1/161 (0.6%) | |
Peritoneal Carcinosis | 1/161 (0.6%) | |
Acute Leukemia | 1/161 (0.6%) | |
Benign Brenner Tumor | 1/161 (0.6%) | |
Benign Prostatic Hypertrophy With Obstruction | 1/161 (0.6%) | |
Hyperechoic Mass Lesions Noted Throughout The Liver with hepatomegaly | 1/161 (0.6%) | |
L Thyroid Mass With Thyroid Lobectomy | 1/161 (0.6%) | |
Poylp-Hyperplastic And 3 Tubular Adenomas | 1/161 (0.6%) | |
Prostate Hyperplasia | 1/161 (0.6%) | |
Malignant Colon Polyp | 1/161 (0.6%) | |
Recurrent Colon Cancer | 1/161 (0.6%) | |
Recurrent Lymphoma | 1/161 (0.6%) | |
Vallecular Cysts | 1/161 (0.6%) | |
Urotheluim Carcinoma | 1/161 (0.6%) | |
Vesical Carcinoma | 1/161 (0.6%) | |
Nervous system disorders | ||
Cerebrovascular Accident/Stroke | 5/161 (3.1%) | |
Acute Encephalopathy | 1/161 (0.6%) | |
Concussion, Laceration | 1/161 (0.6%) | |
Encepalopathy, Multifactorial | 1/161 (0.6%) | |
New Onset Idiopathic Seizures | 1/161 (0.6%) | |
Subacute Subdural Hematoma | 1/161 (0.6%) | |
Worsening Seizures | 1/161 (0.6%) | |
Transient Ischemic Attack (TIA) | 3/161 (1.9%) | |
Product Issues | ||
Device Fracture | 3/161 (1.9%) | |
Illac Limb Occlusion | 5/161 (3.1%) | |
Indeterminate | 1/161 (0.6%) | |
Polymer Leak | 1/161 (0.6%) | |
Type IA (Proximal) | 4/161 (2.5%) | |
Type IB (Distal) | 1/161 (0.6%) | |
Type II | 6/161 (3.7%) | |
Wound Infection | 1/161 (0.6%) | |
Psychiatric disorders | ||
Acute Psychosis | 1/161 (0.6%) | |
Acute Severe Anxiety | 1/161 (0.6%) | |
Acute Severe Depression | 1/161 (0.6%) | |
Altered Mental Status | 1/161 (0.6%) | |
Anxiety/Restlessness | 1/161 (0.6%) | |
Change In Mental Status - Cerebral Cramps And Coma | 1/161 (0.6%) | |
Dementia (w/ Hospitalization) | 1/161 (0.6%) | |
Hospital Admission to Rearrange Psychiatric Medications | 1/161 (0.6%) | |
Worsening Mental Status | 1/161 (0.6%) | |
Renal and urinary disorders | ||
Acute Kidney Injury | 3/161 (1.9%) | |
Anuria | 1/161 (0.6%) | |
Dj Stent Change | 1/161 (0.6%) | |
Hematuria | 1/161 (0.6%) | |
Hydronephrosis | 1/161 (0.6%) | |
Kidney Stone | 1/161 (0.6%) | |
Kidney Stones/Rt Flank Pain/Er Visit | 1/161 (0.6%) | |
Pre-Existing Renal Insufficiency Hospitalization | 2/161 (1.2%) | |
Renal Stone (w/ Admission) | 1/161 (0.6%) | |
Ureteral Surgery | 1/161 (0.6%) | |
Renal Failure | 4/161 (2.5%) | |
Reproductive system and breast disorders | ||
Left Orchyepididimitis, Right Epididimitis | 1/161 (0.6%) | |
Right Testis Hydrocele Surgical Repair | 1/161 (0.6%) | |
Respiratory, thoracic and mediastinal disorders | ||
Acute Respiratory Failure | 6/161 (3.7%) | |
Pneumonia | 11/161 (6.8%) | |
Acute Hypercapnic And Hypoxic Respiratory Failure | 1/161 (0.6%) | |
Pulmonary Embolism | 5/161 (3.1%) | |
Acute Respiratory Acidosis | 1/161 (0.6%) | |
Acute respiratory distress syndrome (ARDS) | 1/161 (0.6%) | |
Chest Stab Wound | 1/161 (0.6%) | |
Chronic obstructive pulmonary disease (COPD) | 1/161 (0.6%) | |
Chronic obstructive pulmonary disease (COPD) Exacerbation | 8/161 (5%) | |
End Stage Chronic obstructive pulmonary disease (COPD) | 1/161 (0.6%) | |
Hypoxia | 2/161 (1.2%) | |
Hypoxiemia/Hypoxia | 1/161 (0.6%) | |
Lung Fibrosis | 1/161 (0.6%) | |
Episode of Heavy Dispnea | 1/161 (0.6%) | |
Pleural Effusion | 1/161 (0.6%) | |
Pleural Effusion, Kard. Decompensation | 1/161 (0.6%) | |
Progression Of Emphysema | 1/161 (0.6%) | |
Respiratory Distress | 1/161 (0.6%) | |
Respiratory Failure | 1/161 (0.6%) | |
Respiratory Failure Secondary to COPD | 1/161 (0.6%) | |
Shortness Of Breath | 1/161 (0.6%) | |
Sinusitis With Dizziness And Flashing Lights | 1/161 (0.6%) | |
Spontaneous Pneumothorax | 1/161 (0.6%) | |
Weakness And Increase Oxygen Demand | 1/161 (0.6%) | |
Worsening COPD And Pulmonary Hypertension | 1/161 (0.6%) | |
Worsening Respiratory Failure Secondary To Septic Shock and MRSA Pneumonia | 1/161 (0.6%) | |
Skin and subcutaneous tissue disorders | ||
Chest Wall Hematoma | 1/161 (0.6%) | |
Cutaneous Rash | 1/161 (0.6%) | |
Decubitus Ulcer | 1/161 (0.6%) | |
Endographic Repair Of Known Thoracic Penetrating Ulcer | 1/161 (0.6%) | |
Hematoma Left Arm | 1/161 (0.6%) | |
Hematoma Left Thigh, Wound Healing Disorder | 1/161 (0.6%) | |
Left Lower Extremity Cellulitis | 1/161 (0.6%) | |
Necrosis Of Right Toe | 1/161 (0.6%) | |
Open Wound, Necrosis | 1/161 (0.6%) | |
Right Hip Incision And Drainage | 2/161 (1.2%) | |
Stage 3 Pressure Ulcer Bilateral Buttocks | 1/161 (0.6%) | |
Ulcera Cruris With Known Paod Iv | 1/161 (0.6%) | |
Social circumstances | ||
Attempted Suicide | 1/161 (0.6%) | |
Mechanical Fall | 1/161 (0.6%) | |
Numerous Falls resulting in Hospitalization | 1/161 (0.6%) | |
Small Subarachnoid Hemorrhage Due To Fall | 1/161 (0.6%) | |
Surgical and medical procedures | ||
Allergic To Contrast Agent | 1/161 (0.6%) | |
Elective Prostatectomy | 1/161 (0.6%) | |
Medication Induced Encephalopathy, Diagnosed With orthostatic hypotension | 1/161 (0.6%) | |
Post-surgical Hematoma, Hydrocele Repair | 1/161 (0.6%) | |
Post-Procedural Hematuria | 1/161 (0.6%) | |
Postoperative Compartment Syndrome Of Rt. Leg Due to Hematoma | 1/161 (0.6%) | |
Vascular disorders | ||
Aneurysm enlargement | 4/161 (2.5%) | |
Aneurysm rupture | 1/161 (0.6%) | |
Aortic Body Stenosis | 1/161 (0.6%) | |
Peripheral Ischemia | 3/161 (1.9%) | |
Ae Code L13. Other Vascular- Supra-Renal Vs. Celiac Aneurysm Rupture | 1/161 (0.6%) | |
Aneurysm Enlargement Due To Type Ii Endoleak | 1/161 (0.6%) | |
Aneurysm Expand Without Endoleak | 1/161 (0.6%) | |
Aneurysm Spurium Of Left Arm | 1/161 (0.6%) | |
Ascending Aortic Aneurysm | 1/161 (0.6%) | |
Bilateral Pulmonary Emboli | 1/161 (0.6%) | |
Claudication (L) Lower Extremity; (L) Stenosis & Urinary retention | 1/161 (0.6%) | |
Extrinsic Compression Aortic Body | 1/161 (0.6%) | |
N2 Left Carotid Endarterectomy | 1/161 (0.6%) | |
N2 Right Carotid Endarterectomy | 1/161 (0.6%) | |
Pseudoaneurysm | 1/161 (0.6%) | |
Pulmonary Hypertension | 1/161 (0.6%) | |
Rt Sfa Occlusion | 1/161 (0.6%) | |
Superior Mesenteric Vein Occlusion | 1/161 (0.6%) | |
Supra Renal Aneurysm Rupture | 1/161 (0.6%) | |
Vasospasm | 1/161 (0.6%) | |
Venous Insufficiency | 1/161 (0.6%) | |
Worsening Perivascular Disease | 1/161 (0.6%) | |
Vascular Occlusion | 3/161 (1.9%) | |
Vascular Trauma | 2/161 (1.2%) | |
Other (Not Including Serious) Adverse Events |
||
Ovation™ Abdominal Stent Graft System | ||
Affected / at Risk (%) | # Events | |
Total | 144/161 (89.4%) | |
Blood and lymphatic system disorders | ||
Coagulopathy | 1/161 (0.6%) | |
Anemia | 5/161 (3.1%) | |
Anemia Due To B12 Deficiency | 1/161 (0.6%) | |
Anemia-Low Hemoglobin And Hematocrit | 1/161 (0.6%) | |
Anemia-Macrocytic | 1/161 (0.6%) | |
Decreased Hematocrit Level | 1/161 (0.6%) | |
Elevated Inr Levels | 1/161 (0.6%) | |
Elevated Wbc | 1/161 (0.6%) | |
Leukocytosis | 3/161 (1.9%) | |
N2- Worsening Of Anemia Post Op | 1/161 (0.6%) | |
Supratherapeutic Inr 8.6 | 1/161 (0.6%) | |
Thrombocytopenia | 1/161 (0.6%) | |
Cardiac disorders | ||
Angina | 7/161 (4.3%) | |
Arrhythmia | 4/161 (2.5%) | |
Congestive Heart Failure | 5/161 (3.1%) | |
Acute Congestive Heart Failure | 1/161 (0.6%) | |
Afib With Rapid Ventricular Response | 1/161 (0.6%) | |
Apical Thrombus | 1/161 (0.6%) | |
Asymptomatic Pvc's During Routine Colonoscopy | 1/161 (0.6%) | |
Atrial Septal Aneurysm | 1/161 (0.6%) | |
Bradycardia | 1/161 (0.6%) | |
Decreased Ef From 35% To 25% | 1/161 (0.6%) | |
High Pulse Rate- Tachycardia | 1/161 (0.6%) | |
Increase Troponin Levels | 1/161 (0.6%) | |
Irregular Heart Beat | 1/161 (0.6%) | |
Pericardial Effusion | 1/161 (0.6%) | |
Tachycardia | 1/161 (0.6%) | |
Congenital, familial and genetic disorders | ||
Pfo | 1/161 (0.6%) | |
Ear and labyrinth disorders | ||
Hearing Loss | 1/161 (0.6%) | |
Hearing Loss Left Ear | 1/161 (0.6%) | |
Otitis Media/Hearing Loss | 1/161 (0.6%) | |
Endocrine disorders | ||
Adrenal Insufficiency | 1/161 (0.6%) | |
Diabetes | 1/161 (0.6%) | |
Diabetic Ketacedosis | 1/161 (0.6%) | |
Elevated Tsh | 1/161 (0.6%) | |
Exacerbation Of Type Ii Diabetes | 1/161 (0.6%) | |
Hypothyroidism | 1/161 (0.6%) | |
Increased Glucose Level | 1/161 (0.6%) | |
Positive Ketones In Urine | 1/161 (0.6%) | |
Eye disorders | ||
Blurred Vision R Eye | 1/161 (0.6%) | |
Ambulatory Elective Cataract Op | 1/161 (0.6%) | |
Bruised Left Eye | 1/161 (0.6%) | |
Cataract In Left Eye | 2/161 (1.2%) | |
Cataract Phacoemulsification Of The Left Eye. | 1/161 (0.6%) | |
Cataract Phacoemulsification Of The Right Eye | 1/161 (0.6%) | |
Conjunctivitis | 1/161 (0.6%) | |
Conjunctivitis Right Eye | 1/161 (0.6%) | |
Incisional Biopsy Of Left Upper Eyelid | 1/161 (0.6%) | |
Macular Degeneration | 1/161 (0.6%) | |
Occular Rosacea | 1/161 (0.6%) | |
Removal Of Cataracts | 1/161 (0.6%) | |
Cataract Right Eye | 3/161 (1.9%) | |
Gastrointestinal disorders | ||
Adynamic ileus | 1/161 (0.6%) | |
Bowel obstruction | 1/161 (0.6%) | |
"stomach Gnawing" | 1/161 (0.6%) | |
Ascites | 1/161 (0.6%) | |
Barrett's Esophagus | 1/161 (0.6%) | |
Barrett's High Grade Dysplasia | 1/161 (0.6%) | |
Blood In Stool | 1/161 (0.6%) | |
Bloody Stools | 1/161 (0.6%) | |
Cholitis With Urinary Retention And Rectal Urgen | 1/161 (0.6%) | |
Colon Polyp | 1/161 (0.6%) | |
Constipation | 4/161 (2.5%) | |
Diarrhea | 1/161 (0.6%) | |
Diverticulosis | 4/161 (2.5%) | |
Dysphagia | 3/161 (1.9%) | |
Esophageal Spasm | 2/161 (1.2%) | |
Gastroesophageal Reflux Disease | 4/161 (2.5%) | |
Gi Bleeding With Esophagil Varicosis | 1/161 (0.6%) | |
Hematemesis | 1/161 (0.6%) | |
Irregular Bowel Movements | 1/161 (0.6%) | |
Nausea | 3/161 (1.9%) | |
Nausea And Vomiting. Etiology | 2/161 (1.2%) | |
Pancreatic Head Lesion | 1/161 (0.6%) | |
Sigma Diverticulosis | 2/161 (1.2%) | |
Upper Gi Bleed | 1/161 (0.6%) | |
Upper Gi Endoscopy - Multiple Thermal Ablation O | 1/161 (0.6%) | |
General disorders | ||
Fever | 4/161 (2.5%) | |
1+ Edema Bilat Lower Extremities | 1/161 (0.6%) | |
1+ Pitting Edema | 1/161 (0.6%) | |
Abdominal Pain | 1/161 (0.6%) | |
Allergic Reaction To Klonopin | 1/161 (0.6%) | |
Arm Pain | 1/161 (0.6%) | |
Atypical Chest Pain. All Cardiac Diagnostic -Neg | 1/161 (0.6%) | |
Back Pain | 5/161 (3.1%) | |
Bilateral Leg Fatigue | 1/161 (0.6%) | |
Bilateral Lower Extremity Edema | 3/161 (1.9%) | |
Bilateral Lower Leg Pain | 1/161 (0.6%) | |
Bruising Of Right Upper Arm | 1/161 (0.6%) | |
Burning Feeling In Chest | 1/161 (0.6%) | |
C/O Hip Pain | 1/161 (0.6%) | |
Calf Pain | 1/161 (0.6%) | |
Chest And Back Pain | 1/161 (0.6%) | |
Chest Pain | 1/161 (0.6%) | |
Chest Pressure | 1/161 (0.6%) | |
Deconditioning | 1/161 (0.6%) | |
Difficulty Sleeping | 1/161 (0.6%) | |
Dizziness | 3/161 (1.9%) | |
Epistaxis | 2/161 (1.2%) | |
Fall At Home | 3/161 (1.9%) | |
False Aneurysma Right Inguinal Side | 1/161 (0.6%) | |
Fatigue | 2/161 (1.2%) | |
Groin Pain | 2/161 (1.2%) | |
Heache/Nausea | 2/161 (1.2%) | |
Increasingly Swollen Lower Extremities | 1/161 (0.6%) | |
Intermittent Groin Pain | 3/161 (1.9%) | |
Intractable Hiccups | 1/161 (0.6%) | |
Laceration Left Thumb | 1/161 (0.6%) | |
Left Flank Pain | 1/161 (0.6%) | |
Left Leg Swelling | 1/161 (0.6%) | |
Left Lower Extremity Edema | 1/161 (0.6%) | |
Left Lower Leg And Ankle 2+ Pitting Edema | 1/161 (0.6%) | |
Legs Feel "rubbery" | 1/161 (0.6%) | |
Lower Back And Leg Pain | 1/161 (0.6%) | |
Malaise- General | 1/161 (0.6%) | |
N2: Pain In Both Inguinal | 1/161 (0.6%) | |
Nausea | 1/161 (0.6%) | |
Night Sweats | 1/161 (0.6%) | |
Pain In Kidney Area | 1/161 (0.6%) | |
Pain In The Right Upper Quadrant Of Abdomen | 1/161 (0.6%) | |
Patient Went To Er For Abdominal Pain | 1/161 (0.6%) | |
Poor Sleep | 1/161 (0.6%) | |
Progressive Lower Limb Weakness | 1/161 (0.6%) | |
Psa-Values Increased | 1/161 (0.6%) | |
Right Ear Pain | 1/161 (0.6%) | |
Right Flank Pain | 1/161 (0.6%) | |
Right Groin Pain | 1/161 (0.6%) | |
Right Hip Pain | 2/161 (1.2%) | |
Right Side Stitch | 1/161 (0.6%) | |
Right Upper Quadrant Abdominal Pain | 1/161 (0.6%) | |
Rt Groin Site Swollen And Burning With Hard Lump | 1/161 (0.6%) | |
Sob While Walking | 1/161 (0.6%) | |
Soreness In Chest | 1/161 (0.6%) | |
Syncope | 2/161 (1.2%) | |
Weakness | 1/161 (0.6%) | |
Worsening Of Lower Extremity Edema | 1/161 (0.6%) | |
Worsening of Restless Leg Syndrome | 1/161 (0.6%) | |
Wound Discomfort | 1/161 (0.6%) | |
osteoarthritis Rt knee | 1/161 (0.6%) | |
Infections and infestations | ||
Infection (other than wound) | 14/161 (8.7%) | |
Cellulitis Left Lower Extremity | 1/161 (0.6%) | |
Helicobacter Pylori | 1/161 (0.6%) | |
Mrsa Bacteremia | 1/161 (0.6%) | |
N2- Herpes Zoster With Postherpetic Neuralgia | 1/161 (0.6%) | |
Recurrent Left Lower Extremity Cellulitis | 1/161 (0.6%) | |
Right Lower Extremity Infection | 1/161 (0.6%) | |
Shingles | 1/161 (0.6%) | |
Sinus Infection | 1/161 (0.6%) | |
Subclinical Shingles Outbreak | 1/161 (0.6%) | |
Tooth Absess | 1/161 (0.6%) | |
Urinary Tract Infection | 1/161 (0.6%) | |
Urinary Tract Infection Due To Chronic Indwelling Foley Catheter | 1/161 (0.6%) | |
Wound Infection | 3/161 (1.9%) | |
Metabolism and nutrition disorders | ||
Calcium Level Remains Below Normal At 8.2 | 1/161 (0.6%) | |
Dehydration | 2/161 (1.2%) | |
Hypomagnesemia | 2/161 (1.2%) | |
Low Vitamin D | 1/161 (0.6%) | |
Metabolic Acidosis | 1/161 (0.6%) | |
Paraproteinemia Protein 10.2 | 1/161 (0.6%) | |
Protein Malnutrition | 1/161 (0.6%) | |
Unintentional Weight Loss | 1/161 (0.6%) | |
Vitamin B12 Deficiency | 1/161 (0.6%) | |
Musculoskeletal and connective tissue disorders | ||
Back pain | 4/161 (2.5%) | |
Carpal Tunnel Injection | 1/161 (0.6%) | |
Carpal Tunnel sundrome | 1/161 (0.6%) | |
DDD lower spine | 1/161 (0.6%) | |
Foot drop | 1/161 (0.6%) | |
Lt. knee pain | 1/161 (0.6%) | |
Neck pain | 1/161 (0.6%) | |
Pain Shoulder | 1/161 (0.6%) | |
Rt knee pain, torn tissue | 1/161 (0.6%) | |
Rt achilles injury/tear | 1/161 (0.6%) | |
Rt hip pain | 1/161 (0.6%) | |
Rt knee pain- arthritis | 1/161 (0.6%) | |
Acute Synovitis | 1/161 (0.6%) | |
Advanced Tooth Carie With Acute Pain | 1/161 (0.6%) | |
Bilateral Hernia Inguinal Hernia Repair | 1/161 (0.6%) | |
Bilateral Inguinal Hernias | 1/161 (0.6%) | |
Bursitis Olecrani Right Side | 1/161 (0.6%) | |
Compression Injury Upper Thoracic Spine Vertebra | 1/161 (0.6%) | |
Dental Caries With Lip Ulcer | 1/161 (0.6%) | |
Exacerbation Of Degenerative Joint Disease | 1/161 (0.6%) | |
Inguinal Hernia | 1/161 (0.6%) | |
Left Inguinal Hernia | 1/161 (0.6%) | |
Lumbar Spondylosis, Lumbar Facet Arthropathy | 1/161 (0.6%) | |
Musculoskeletal- Myalgias | 1/161 (0.6%) | |
Pain Upper Leg And Sural Muscle | 1/161 (0.6%) | |
Right Inguinal Hernia Incarceration | 1/161 (0.6%) | |
Right Knee/Calf Numbness | 1/161 (0.6%) | |
Sprained Left Wrist/Inflammatory Arthritis | 1/161 (0.6%) | |
T12 compression fracture | 1/161 (0.6%) | |
Thoracic Vertebra broken | 1/161 (0.6%) | |
Torn right rotator cuff | 1/161 (0.6%) | |
compression fx vertebrae | 1/161 (0.6%) | |
left achilles tendinosis | 1/161 (0.6%) | |
left hip pain | 1/161 (0.6%) | |
leg pain | 1/161 (0.6%) | |
right elbow strain | 1/161 (0.6%) | |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Skin Cancer | 2/161 (1.2%) | |
Large Seroma | 1/161 (0.6%) | |
Ct Guide Lung Biopsy Of Pulmonary Nodule | 1/161 (0.6%) | |
Excision Basaliom At Left Upper Arm | 1/161 (0.6%) | |
Generalized Intermittent Pain Secondary To Metas | 1/161 (0.6%) | |
Increasing Psa With Known Prostate Cancer | 1/161 (0.6%) | |
Squamous Cell Carcinoma | 1/161 (0.6%) | |
Nervous system disorders | ||
Paresthesia | 3/161 (1.9%) | |
Benign Essential Tremor | 1/161 (0.6%) | |
Bilateral Numbness In Feet | 1/161 (0.6%) | |
Contusion Cerebra | 1/161 (0.6%) | |
Exacerbation Of Sciatica | 1/161 (0.6%) | |
Leg Weakness And Vertigo | 1/161 (0.6%) | |
Mild Dementia/Memory Dysfunction/Cerebral De-Gen | 1/161 (0.6%) | |
Neurologic/Musculoskeletal Pain Left Upper Extre | 1/161 (0.6%) | |
Neurological Changes | 1/161 (0.6%) | |
Normal Pressure Hydrocephalus | 1/161 (0.6%) | |
Questionable Seizure | 1/161 (0.6%) | |
Self Limited Tremor Of Head & Left Upper Limb, 1 | 1/161 (0.6%) | |
Syncope, Confusion, Light Headedness | 1/161 (0.6%) | |
Vertigo/Headache | 1/161 (0.6%) | |
Transient Ischemic Attack | 1/161 (0.6%) | |
Product Issues | ||
Device Fracture | 4/161 (2.5%) | |
Indeterminate | 1/161 (0.6%) | |
Type II Endoleak | 83/161 (51.6%) | |
Type IA (Proximal) | 2/161 (1.2%) | |
Type IIIA (Disconnectino/Disjunction) | 1/161 (0.6%) | |
Psychiatric disorders | ||
Anxiety | 1/161 (0.6%) | |
Dementia | 3/161 (1.9%) | |
Increasing Memory Loss | 1/161 (0.6%) | |
Mental Status Changes | 1/161 (0.6%) | |
Mild Confusion | 1/161 (0.6%) | |
Worsening Anxiety | 1/161 (0.6%) | |
Worsening Depression | 1/161 (0.6%) | |
Renal and urinary disorders | ||
Renal Failure | 3/161 (1.9%) | |
Renal Insufficiency | 6/161 (3.7%) | |
Acute Kidney Injury With High Potassium | 1/161 (0.6%) | |
Bladder Dome Mucosal Nodule | 1/161 (0.6%) | |
Bph | 1/161 (0.6%) | |
Cystitis | 1/161 (0.6%) | |
Hematuria | 3/161 (1.9%) | |
Hydronephrosis | 1/161 (0.6%) | |
Hypercalcemia | 1/161 (0.6%) | |
Increased Bun Level | 2/161 (1.2%) | |
Increased Creatinine Level | 1/161 (0.6%) | |
Intermittent Urinary Tract Infection | 1/161 (0.6%) | |
Kidney Infection | 2/161 (1.2%) | |
Microhematuria | 1/161 (0.6%) | |
Polyuria | 1/161 (0.6%) | |
Renal Insufficiency | 1/161 (0.6%) | |
Renal Masses Increase In Size | 1/161 (0.6%) | |
Rt Kidney Cyst With Mild Thickening | 1/161 (0.6%) | |
Urinary Tract Infection | 3/161 (1.9%) | |
Worsening Renal Insufficiency | 1/161 (0.6%) | |
Worsening Renal Insufficiency Ckd Stage III | 1/161 (0.6%) | |
Worsening Renal Insufficiency Ckd Stage IV | 1/161 (0.6%) | |
Urinary Retention | 4/161 (2.5%) | |
Reproductive system and breast disorders | ||
Impotence | 1/161 (0.6%) | |
Right Spermocele | 1/161 (0.6%) | |
Respiratory, thoracic and mediastinal disorders | ||
Hemothorax | 1/161 (0.6%) | |
Pneumonia | 6/161 (3.7%) | |
Pneumothorax | 1/161 (0.6%) | |
Pulmonary Embolism | 2/161 (1.2%) | |
Acute Bronchitis | 2/161 (1.2%) | |
Acute Sinusitis, Maxillary | 1/161 (0.6%) | |
Allergic Rhinitis | 1/161 (0.6%) | |
Aspiration Pneumonitis | 1/161 (0.6%) | |
Bibasilar Atelectasis | 1/161 (0.6%) | |
Bilateral Pleural Effusions | 1/161 (0.6%) | |
Bronchitis | 4/161 (2.5%) | |
Centrilobular And Paraseptal Emphysema | 1/161 (0.6%) | |
Congestion | 1/161 (0.6%) | |
Copd | 3/161 (1.9%) | |
Copd Exacerbation | 2/161 (1.2%) | |
Cough | 3/161 (1.9%) | |
Dyspnea | 6/161 (3.7%) | |
Emphysematous Changes In Lungs | 2/161 (1.2%) | |
Exacerbated Chronic Obstructive Pulmonary Disease | 1/161 (0.6%) | |
Focal Bronciolitis | 1/161 (0.6%) | |
Hypoxia And Copd Exacerbation | 1/161 (0.6%) | |
Left Pleural Effusion | 2/161 (1.2%) | |
New 5 Mm Nodule Right Lower Lobe, Nonspecific | 1/161 (0.6%) | |
Non-Cardiac Pleuritic Pain | 1/161 (0.6%) | |
Non-Productive Cough | 1/161 (0.6%) | |
Pleuritic Chest Pain | 1/161 (0.6%) | |
Productive Cough With Yellow Sputum | 1/161 (0.6%) | |
Pulmonary Fibrosis- Amiodarone Related | 1/161 (0.6%) | |
Pulmonary Nodules | 1/161 (0.6%) | |
Right Pleual Effusion | 1/161 (0.6%) | |
Short Of Breath | 3/161 (1.9%) | |
Small Right Pleural Effusion | 1/161 (0.6%) | |
sob | 1/161 (0.6%) | |
Upper Lobe Infiltrate | 1/161 (0.6%) | |
Upper Respiratory Infection | 1/161 (0.6%) | |
Skin and subcutaneous tissue disorders | ||
Anterior Ankle Ulcer | 1/161 (0.6%) | |
Bilat Feet Non-Healing Sores | 1/161 (0.6%) | |
Decubitus Ulcer | 1/161 (0.6%) | |
Erythema Over Doral Aspect Of Left Foot | 1/161 (0.6%) | |
Fall With Facial Abrasions | 1/161 (0.6%) | |
Intertrigo | 1/161 (0.6%) | |
Laceration Of Small Right Toe | 1/161 (0.6%) | |
Left Foot Ulcer | 1/161 (0.6%) | |
Lipoma Excision | 1/161 (0.6%) | |
Mild Wound Ecchymosis | 1/161 (0.6%) | |
Petechial Rash On Shins Related To Chemotherapy | 1/161 (0.6%) | |
Rash | 2/161 (1.2%) | |
Sebaceous Cyst Right Posterior Neck | 1/161 (0.6%) | |
Skin Biopsies | 1/161 (0.6%) | |
Skin Integrity | 1/161 (0.6%) | |
Suspect Birthmark | 1/161 (0.6%) | |
Surgical and medical procedures | ||
Intraoperative Bleeding | 8/161 (5%) | |
Lymphocele/Lymphatic Fistula | 1/161 (0.6%) | |
Acute Blood Loss Anemia Following Orif | 1/161 (0.6%) | |
Bilateral Groin Erythema | 1/161 (0.6%) | |
Cr 1.7. Ct Was Done W/O Contrast and Ultrasound | 1/161 (0.6%) | |
Erythema Around Groin Incision | 1/161 (0.6%) | |
Incisional Hernia After Nephrectomia | 1/161 (0.6%) | |
Iv Dye Reaction | 1/161 (0.6%) | |
Pain Over Acid | 1/161 (0.6%) | |
Post Operative Anemia | 1/161 (0.6%) | |
Post-Operative Incisional Pain | 1/161 (0.6%) | |
Prolonged Intubation Because Of Anesthesia | 1/161 (0.6%) | |
Reaction During Ct Scan | 1/161 (0.6%) | |
Right Groin 1mm Opening | 1/161 (0.6%) | |
Vancomycin Toxicity | 1/161 (0.6%) | |
Slight Reaction To Contrast Medium | 1/161 (0.6%) | |
Vascular disorders | ||
Aneurysm enlargement | 6/161 (3.7%) | |
Aortic Body Stenosis | 1/161 (0.6%) | |
Deep Vein Thrombosis | 2/161 (1.2%) | |
Dissection | 2/161 (1.2%) | |
Hypertension | 6/161 (3.7%) | |
Hypotension | 10/161 (6.2%) | |
Peripheral Ischemia | 1/161 (0.6%) | |
Aneurysm Enlargement | 1/161 (0.6%) | |
Celiac Artery Stenosis | 2/161 (1.2%) | |
Dissection Of Right External Iliac Artery | 1/161 (0.6%) | |
Dvt | 1/161 (0.6%) | |
Left Carotid Artery Stenosis | 1/161 (0.6%) | |
Left Iliac Limb Stenosis | 1/161 (0.6%) | |
Left Renal Artery Calcified Plaque | 1/161 (0.6%) | |
Left Renal Artery Stenosis | 2/161 (1.2%) | |
Malfunctioning Valves In Right Great Saphenous V | 1/161 (0.6%) | |
Multiple Peripheral Cns Emboli | 1/161 (0.6%) | |
Obstruction Of Illiac Arteries Without Symptoms | 1/161 (0.6%) | |
Petechial Hemorrhage | 1/161 (0.6%) | |
Progression Of Pvd Stenosis Left External Iliac | 1/161 (0.6%) | |
Right Carotid Stenosis | 1/161 (0.6%) | |
Right Common Femoral Artery Aneurysm | 1/161 (0.6%) | |
Right Renal Artery Stenosis | 1/161 (0.6%) | |
S/P Taa Endorepair Now With Type Ii Endoleak | 1/161 (0.6%) | |
Small Ascending Thoracic Aneurysm | 1/161 (0.6%) | |
Stenosis Right Renal Artery | 1/161 (0.6%) | |
Superficial Acute Thrombophlebitis | 1/161 (0.6%) | |
Superficial Phlebitis L Upper Extremity | 1/161 (0.6%) | |
Thoracic Aortic Aneurysm | 2/161 (1.2%) | |
Uncontrolled Hypertension | 1/161 (0.6%) | |
Worsening Claudication | 1/161 (0.6%) | |
Worsening Hypertension | 1/161 (0.6%) | |
Vascular Occlusion | 1/161 (0.6%) | |
Left Upper Lip Laceration | 1/161 (0.6%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between the Principal Investigator and the Sponsor (or itsagents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. PI can publish institution's data/results 18 months after study conclusion at all sites or when multi-center results are published or notification that results will not be published. Institution is to submit drafts of manuscripts to Endologix 30 days prior to submission for publication or presentation.
Results Point of Contact
Name/Title | Manager, Clinical Affairs |
---|---|
Organization | Endologix |
Phone | 864-270-8524 |
nsmith@endologix.com |
- 771-0006