Trial Outcomes & Findings for Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System (NCT NCT01092117)
NCT ID: NCT01092117
Last Updated: 2021-12-21
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
161 participants
Primary outcome timeframe
30 days
Results posted on
2021-12-21
Participant Flow
Participant milestones
| Measure |
Ovation™ Abdominal Stent Graft System
Implant of Ovation™ Abdominal Stent Graft System
Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System
|
|---|---|
|
Index Procedure to 1 Month
STARTED
|
161
|
|
Index Procedure to 1 Month
COMPLETED
|
160
|
|
Index Procedure to 1 Month
NOT COMPLETED
|
1
|
|
1 Month
STARTED
|
160
|
|
1 Month
COMPLETED
|
157
|
|
1 Month
NOT COMPLETED
|
3
|
|
6 Months
STARTED
|
157
|
|
6 Months
COMPLETED
|
152
|
|
6 Months
NOT COMPLETED
|
5
|
|
12 Month
STARTED
|
152
|
|
12 Month
COMPLETED
|
138
|
|
12 Month
NOT COMPLETED
|
14
|
|
Year 2
STARTED
|
138
|
|
Year 2
COMPLETED
|
128
|
|
Year 2
NOT COMPLETED
|
10
|
|
Year 3
STARTED
|
128
|
|
Year 3
COMPLETED
|
109
|
|
Year 3
NOT COMPLETED
|
19
|
|
Year 4
STARTED
|
109
|
|
Year 4
COMPLETED
|
93
|
|
Year 4
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Ovation™ Abdominal Stent Graft System
Implant of Ovation™ Abdominal Stent Graft System
Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System
|
|---|---|
|
Index Procedure to 1 Month
Death
|
1
|
|
1 Month
Death
|
1
|
|
1 Month
Withdrawal by Subject
|
1
|
|
1 Month
Lost to Follow-up
|
1
|
|
6 Months
Death
|
2
|
|
6 Months
Withdrawal by Subject
|
3
|
|
12 Month
Death
|
11
|
|
12 Month
Withdrawal by Subject
|
2
|
|
12 Month
Lost to Follow-up
|
1
|
|
Year 2
Death
|
5
|
|
Year 2
Withdrawal by Subject
|
4
|
|
Year 2
Lost to Follow-up
|
1
|
|
Year 3
Death
|
7
|
|
Year 3
Withdrawal by Subject
|
9
|
|
Year 3
Lost to Follow-up
|
3
|
|
Year 4
Death
|
8
|
|
Year 4
Withdrawal by Subject
|
4
|
|
Year 4
Lost to Follow-up
|
4
|
Baseline Characteristics
Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System
Baseline characteristics by cohort
| Measure |
Ovation™ Abdominal Stent Graft System
n=161 Participants
Implant of Ovation™ Abdominal Stent Graft System
Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System
|
|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
20 participants
n=5 Participants
|
|
American Society of Anesthesiology (ASA) Grade
ASA Grade I
|
9 Participants
n=5 Participants
|
|
American Society of Anesthesiology (ASA) Grade
ASA Grade II
|
45 Participants
n=5 Participants
|
|
American Society of Anesthesiology (ASA) Grade
ASA Grade III
|
96 Participants
n=5 Participants
|
|
American Society of Anesthesiology (ASA) Grade
ASA Grade IV
|
11 Participants
n=5 Participants
|
|
Cardiovascular Disease
Coronary artery disease
|
72 Participants
n=5 Participants
|
|
Cardiovascular Disease
Valvular heart disease
|
19 Participants
n=5 Participants
|
|
Cardiovascular Disease
Angina
|
11 Participants
n=5 Participants
|
|
Cardiovascular Disease
Cardiomyopathy
|
11 Participants
n=5 Participants
|
|
Cardiovascular Disease
Congestive Heart Failure
|
12 Participants
n=5 Participants
|
|
Cardiovascular Disease
Myocardial infarction
|
33 Participants
n=5 Participants
|
|
Cardiovascular Disease
Arrhythmia
|
35 Participants
n=5 Participants
|
|
Cardiovascular Disease
Hypertension
|
136 Participants
n=5 Participants
|
|
Cardiovascular Disease
Hypotension
|
1 Participants
n=5 Participants
|
|
Cardiovascular Disease
Hyperlipidemia
|
113 Participants
n=5 Participants
|
|
Peripheral Vascular Disease, Stroke and Aneurysm History
Peripheral vascular disease
|
38 Participants
n=5 Participants
|
|
Peripheral Vascular Disease, Stroke and Aneurysm History
Carotid artery disease
|
21 Participants
n=5 Participants
|
|
Peripheral Vascular Disease, Stroke and Aneurysm History
Transient ischemic attack
|
8 Participants
n=5 Participants
|
|
Peripheral Vascular Disease, Stroke and Aneurysm History
Stroke (CVA)
|
13 Participants
n=5 Participants
|
|
Peripheral Vascular Disease, Stroke and Aneurysm History
Family History of aneurysms
|
10 Participants
n=5 Participants
|
|
Pulmonary History
Smoking
|
113 Participants
n=5 Participants
|
|
Pulmonary History
Chronic obstructive pulmonary disease (COPD)
|
44 Participants
n=5 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Renal failure/insufficiency
|
22 Participants
n=5 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Diabetes
|
34 Participants
n=5 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Alcohol abuse
|
3 Participants
n=5 Participants
|
|
Hematological Problems (hemorrhage, coagulopathy disorder, anemia, platelet disorder)
|
12 Participants
n=5 Participants
|
|
Other Significant Medical Condition
|
122 Participants
n=5 Participants
|
|
Proximal Aorta
Aortic diameter 35 mm proximal to proximal renal artery
|
25.0 mm
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Proximal Aorta
Aortic diameter at distal renal artery
|
22.5 mm
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Proximal Aorta
Aortic diameter 7 mm distal to distal renal artery
|
22.1 mm
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Proximal Aorta
Aortic diameter 13 mm distal to distal renal artery
|
22.7 mm
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Proximal Aorta
Proximal neck length
|
23.0 mm
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Proximal Aorta-Juxtarenal angle
|
19.1 Degrees
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Aortic Aneurysm-Aortic aneurysm diameter
|
53.6 mm
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Aortic aneurysm diameter distribution
40.0mm-49.9mm
|
57 Participants
n=5 Participants
|
|
Aortic aneurysm diameter distribution
50.0mm-59.9mm
|
81 Participants
n=5 Participants
|
|
Aortic aneurysm diameter distribution
60.0mm-69.9mm
|
14 Participants
n=5 Participants
|
|
Aortic aneurysm diameter distribution
70.0mm-79.9mm
|
5 Participants
n=5 Participants
|
|
Aortic aneurysm diameter distribution
80.0mm-89.9mm
|
2 Participants
n=5 Participants
|
|
Aortic aneurysm diameter distribution
90.0mm-99.9mm
|
2 Participants
n=5 Participants
|
|
Distal Aorta
Aortic bifurcation diameter
|
20.3 mm
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Distal Aorta
Left iliac diameter
|
13.7 mm
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Distal Aorta
Left iliac minimum access diameter
|
7.0 mm
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Distal Aorta
Right iliac diameter
|
13.9 mm
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Distal Aorta
Right iliac minimum access diameter
|
7.0 mm
STANDARD_DEVIATION 1.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysMajor 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)
Outcome measures
| Measure |
Ovation™ Abdominal Stent Graft System
n=161 Participants
Implant of Ovation™ Abdominal Stent Graft System
Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System
|
|---|---|
|
The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure.
|
4 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 138 subjects completed study through 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.
Outcome measures
| Measure |
Ovation™ Abdominal Stent Graft System
n=138 Participants
Implant of Ovation™ Abdominal Stent Graft System
Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System
|
|---|---|
|
The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success.
|
137 Participants
|
Adverse Events
Ovation™ Abdominal Stent Graft System
Serious events: 129 serious events
Other events: 144 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Ovation™ Abdominal Stent Graft System
n=161 participants at risk
Implant of Ovation™ Abdominal Stent Graft System
Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System
|
|---|---|
|
Blood and lymphatic system disorders
Hematoma
|
2.5%
4/161 • 5 years
|
|
Blood and lymphatic system disorders
Post-procedureal Bleeding
|
2.5%
4/161 • 5 years
|
|
Blood and lymphatic system disorders
Acute Blood Loss
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation with Septic Shock
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Elevated White Blood Cells
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Heparin Induced Thrombocytopenia
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Lymphatic leak
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Polycythaemia Vera
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Severe Anemia Secondary To Myelodisplasia
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Subararchnoidal Bleeding
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Angina
|
3.7%
6/161 • 5 years
|
|
Cardiac disorders
Arrhythmia
|
4.3%
7/161 • 5 years
|
|
Cardiac disorders
Congestive Heart Failure
|
6.2%
10/161 • 5 years
|
|
Cardiac disorders
Hypertension
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Hypotension
|
1.9%
3/161 • 5 years
|
|
Cardiac disorders
Myocardial Infarction
|
3.7%
6/161 • 5 years
|
|
Cardiac disorders
Atrial fibrillation with RVR
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Atrial fibrillation With Rapid Ventricular Response
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Aortic Valve Stenosis
|
1.9%
3/161 • 5 years
|
|
Cardiac disorders
Cardiac Arrest
|
1.2%
2/161 • 5 years
|
|
Cardiac disorders
Cardiogenic Shock
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Coronary Artery Disease: Chest Pain, Le Edema, Ruq Abdominal Pain
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Mitral Reguritation
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Severe Aortic Stenosis
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Sinoatrial Node Dysfunction
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Tricuspid Regurgitation
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Unstable Angina
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Worsening Atrial Fibrillation
|
1.2%
2/161 • 5 years
|
|
Cardiac disorders
Worsening Chronic Heart Disease
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Worsening Congestive Heart Failure
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Thyreoidectomy
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Circulatory Disorder Left Eye
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Surgical Procedure: pars-Plana Vitrectomy, Cerclage and Kryocoagulation right Eye
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Adynamic ileus
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Bowel ischemia
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Infection (other than wound)
|
5.0%
8/161 • 5 years
|
|
Gastrointestinal disorders
Acute On Chronic Pancreatitis
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Air in Intestine
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Bleeding Duodenal Ulcer
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Bloody Stools
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Bowel Perforation
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Cholecystitis
|
1.2%
2/161 • 5 years
|
|
Gastrointestinal disorders
Choledocholithiasis
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Dilated Biliary Ducts
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Diverticulitis
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Duodenal Angiodysplasia
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Gastrointenstinal Bleed
|
3.1%
5/161 • 5 years
|
|
Gastrointestinal disorders
Hematochezia
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids With Hematochezia
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Ischemic Colitis
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Nausea W/ Vomiting
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Urinary Retention
|
1.9%
3/161 • 5 years
|
|
Gastrointestinal disorders
Fever
|
1.2%
2/161 • 5 years
|
|
General disorders
Bilateral Leg Weakness
|
0.62%
1/161 • 5 years
|
|
General disorders
Chest Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Chest Tightness/Non-Cardiac Chest Pain
|
1.2%
2/161 • 5 years
|
|
General disorders
Collapse
|
0.62%
1/161 • 5 years
|
|
General disorders
Death
|
0.62%
1/161 • 5 years
|
|
General disorders
Death from unknown cause
|
1.2%
2/161 • 5 years
|
|
General disorders
Dizziness
|
0.62%
1/161 • 5 years
|
|
General disorders
Epigastric/Substernal Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Groin Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Groin Pain Inguinal Hernia
|
0.62%
1/161 • 5 years
|
|
General disorders
Leg Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Lightheaded
|
0.62%
1/161 • 5 years
|
|
General disorders
Lower Extremity Edema
|
0.62%
1/161 • 5 years
|
|
General disorders
Lumbar And Right Lower Extremity Severe Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Near Syncope/Weakness
|
0.62%
1/161 • 5 years
|
|
General disorders
Necrosis
|
0.62%
1/161 • 5 years
|
|
General disorders
Right Lower Extremity Significant Swelling W/Edema
|
0.62%
1/161 • 5 years
|
|
General disorders
Right Upper Quadrant Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Syncope
|
1.9%
3/161 • 5 years
|
|
General disorders
Abdominal and Chest Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Syncope Related To Blood Loss From Chest Wall Hematoma
|
0.62%
1/161 • 5 years
|
|
General disorders
Unknown at this time- awaiting hospital records
|
0.62%
1/161 • 5 years
|
|
General disorders
Worsening Claudication
|
0.62%
1/161 • 5 years
|
|
General disorders
Worsening Lower Back And Leg Pain
|
0.62%
1/161 • 5 years
|
|
Immune system disorders
Anaphylactic Shock
|
0.62%
1/161 • 5 years
|
|
Immune system disorders
Anaphylaxis
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Abdominal Sepsis
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Acute Pyelonephritis
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
C-Diff Infection
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Erysipel
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Fungal Infection In Groin
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Herpes Zoster, Left Lumbar Pain And Echymosis
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Pneumonia-MRSA
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Respiratory Infection
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Sepsis
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Septic Right Knee Joint
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Septic Shock
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Spontaneous Bacterial Peritonitis
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Urinary Tract Infection By Hydronephrosis
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Viral Encephalopathy
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Wound Infection
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.2%
2/161 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Lactic Acidosis With Liver Failure
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Severe Hyponatremia
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Broken Shoulder
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Effusion of the left hip
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Fall-fx R prox humerous
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture right hip
|
1.2%
2/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
J1 DJD L hip
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
L1 Compression Fracture
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Left hip fracture
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Left knee arthroplasty
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
R Knee Arthroplasty
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
R Knee spacer removal
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Right femur fracture
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Acute Gout Left Knee
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Acute Gouty Arthritis
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Acute Onset Of Chronic Polyarthitis
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Elective Right Total Hip Arthroplasty
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Gait Weakness/Progressive Decline
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Groin Hernia
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Incarcerated L Inguinal Hernia
|
1.2%
2/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Incarcerated Left Inguinal Hernia With Secondary small bowel obstruction
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Rupture Tendons Right Shoulder. Arthroscopic Repair
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
artificial Knee joint
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.2%
2/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
endoprothesis of right knee
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
enstage cuff tear arthrop
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
fractured left hip
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
hip-tep surgery right
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
hip/back pain
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
impingement-syndrome
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
lumbal spinal stenosis
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis, right hip
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain left knee
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Quadricept tendon rupture
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Right knee revision
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder
|
1.9%
3/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Carcinoma
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mass In Liver
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastic Adenocarcinoma
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
1.2%
2/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal Skin Cancer
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal Carcinosis
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Leukemia
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Brenner Tumor
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Prostatic Hypertrophy With Obstruction
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hyperechoic Mass Lesions Noted Throughout The Liver with hepatomegaly
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
L Thyroid Mass With Thyroid Lobectomy
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Poylp-Hyperplastic And 3 Tubular Adenomas
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Hyperplasia
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Colon Polyp
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent Colon Cancer
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent Lymphoma
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vallecular Cysts
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urotheluim Carcinoma
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vesical Carcinoma
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Cerebrovascular Accident/Stroke
|
3.1%
5/161 • 5 years
|
|
Nervous system disorders
Acute Encephalopathy
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Concussion, Laceration
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Encepalopathy, Multifactorial
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
New Onset Idiopathic Seizures
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Subacute Subdural Hematoma
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Worsening Seizures
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
1.9%
3/161 • 5 years
|
|
Product Issues
Device Fracture
|
1.9%
3/161 • 5 years
|
|
Product Issues
Illac Limb Occlusion
|
3.1%
5/161 • 5 years
|
|
Product Issues
Indeterminate
|
0.62%
1/161 • 5 years
|
|
Product Issues
Polymer Leak
|
0.62%
1/161 • 5 years
|
|
Product Issues
Type IA (Proximal)
|
2.5%
4/161 • 5 years
|
|
Product Issues
Type IB (Distal)
|
0.62%
1/161 • 5 years
|
|
Product Issues
Type II
|
3.7%
6/161 • 5 years
|
|
Product Issues
Wound Infection
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Acute Psychosis
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Acute Severe Anxiety
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Acute Severe Depression
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Altered Mental Status
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Anxiety/Restlessness
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Change In Mental Status - Cerebral Cramps And Coma
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Dementia (w/ Hospitalization)
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Hospital Admission to Rearrange Psychiatric Medications
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Worsening Mental Status
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.9%
3/161 • 5 years
|
|
Renal and urinary disorders
Anuria
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Dj Stent Change
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Kidney Stone
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Kidney Stones/Rt Flank Pain/Er Visit
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Pre-Existing Renal Insufficiency Hospitalization
|
1.2%
2/161 • 5 years
|
|
Renal and urinary disorders
Renal Stone (w/ Admission)
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Ureteral Surgery
|
0.62%
1/161 • 5 years
|
|
Reproductive system and breast disorders
Left Orchyepididimitis, Right Epididimitis
|
0.62%
1/161 • 5 years
|
|
Reproductive system and breast disorders
Right Testis Hydrocele Surgical Repair
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.7%
6/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.8%
11/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypercapnic And Hypoxic Respiratory Failure
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.1%
5/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Acidosis
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome (ARDS)
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chest Stab Wound
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD) Exacerbation
|
5.0%
8/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
End Stage Chronic obstructive pulmonary disease (COPD)
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
2/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxiemia/Hypoxia
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung Fibrosis
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Episode of Heavy Dispnea
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion, Kard. Decompensation
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Progression Of Emphysema
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure Secondary to COPD
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis With Dizziness And Flashing Lights
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Spontaneous Pneumothorax
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Weakness And Increase Oxygen Demand
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Worsening COPD And Pulmonary Hypertension
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Respiratory Failure Secondary To Septic Shock and MRSA Pneumonia
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Chest Wall Hematoma
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Cutaneous Rash
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Endographic Repair Of Known Thoracic Penetrating Ulcer
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hematoma Left Arm
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hematoma Left Thigh, Wound Healing Disorder
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Left Lower Extremity Cellulitis
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Necrosis Of Right Toe
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Open Wound, Necrosis
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Right Hip Incision And Drainage
|
1.2%
2/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Stage 3 Pressure Ulcer Bilateral Buttocks
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Ulcera Cruris With Known Paod Iv
|
0.62%
1/161 • 5 years
|
|
Social circumstances
Attempted Suicide
|
0.62%
1/161 • 5 years
|
|
Social circumstances
Mechanical Fall
|
0.62%
1/161 • 5 years
|
|
Social circumstances
Numerous Falls resulting in Hospitalization
|
0.62%
1/161 • 5 years
|
|
Social circumstances
Small Subarachnoid Hemorrhage Due To Fall
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Allergic To Contrast Agent
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Elective Prostatectomy
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Medication Induced Encephalopathy, Diagnosed With orthostatic hypotension
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Post-surgical Hematoma, Hydrocele Repair
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Post-Procedural Hematuria
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Postoperative Compartment Syndrome Of Rt. Leg Due to Hematoma
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Aneurysm enlargement
|
2.5%
4/161 • 5 years
|
|
Vascular disorders
Aneurysm rupture
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Aortic Body Stenosis
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Peripheral Ischemia
|
1.9%
3/161 • 5 years
|
|
Vascular disorders
Ae Code L13. Other Vascular- Supra-Renal Vs. Celiac Aneurysm Rupture
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Aneurysm Enlargement Due To Type Ii Endoleak
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Aneurysm Expand Without Endoleak
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Aneurysm Spurium Of Left Arm
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Ascending Aortic Aneurysm
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Bilateral Pulmonary Emboli
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Claudication (L) Lower Extremity; (L) Stenosis & Urinary retention
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Extrinsic Compression Aortic Body
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
N2 Left Carotid Endarterectomy
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
N2 Right Carotid Endarterectomy
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Pseudoaneurysm
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Pulmonary Hypertension
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Rt Sfa Occlusion
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Superior Mesenteric Vein Occlusion
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Supra Renal Aneurysm Rupture
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Vasospasm
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Venous Insufficiency
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Worsening Perivascular Disease
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Vascular Occlusion
|
1.9%
3/161 • 5 years
|
|
Vascular disorders
Vascular Trauma
|
1.2%
2/161 • 5 years
|
|
Renal and urinary disorders
Renal Failure
|
2.5%
4/161 • 5 years
|
Other adverse events
| Measure |
Ovation™ Abdominal Stent Graft System
n=161 participants at risk
Implant of Ovation™ Abdominal Stent Graft System
Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System
|
|---|---|
|
Renal and urinary disorders
Hydronephrosis
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Hypercalcemia
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Increased Bun Level
|
1.2%
2/161 • 5 years
|
|
Renal and urinary disorders
Increased Creatinine Level
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Intermittent Urinary Tract Infection
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Kidney Infection
|
1.2%
2/161 • 5 years
|
|
Renal and urinary disorders
Microhematuria
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Polyuria
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Renal Insufficiency
|
3.7%
6/161 • 5 years
|
|
Renal and urinary disorders
Renal Masses Increase In Size
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Rt Kidney Cyst With Mild Thickening
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.9%
3/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Thoracic Vertebra broken
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Torn right rotator cuff
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
compression fx vertebrae
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
left achilles tendinosis
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
left hip pain
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
0.62%
1/161 • 5 years
|
|
General disorders
osteoarthritis Rt knee
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
right elbow strain
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
1.2%
2/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Seroma
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ct Guide Lung Biopsy Of Pulmonary Nodule
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Excision Basaliom At Left Upper Arm
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Generalized Intermittent Pain Secondary To Metas
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Increasing Psa With Known Prostate Cancer
|
0.62%
1/161 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Paresthesia
|
1.9%
3/161 • 5 years
|
|
Nervous system disorders
Benign Essential Tremor
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Bilateral Numbness In Feet
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Contusion Cerebra
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Exacerbation Of Sciatica
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Leg Weakness And Vertigo
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Mild Dementia/Memory Dysfunction/Cerebral De-Gen
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Neurologic/Musculoskeletal Pain Left Upper Extre
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Neurological Changes
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Normal Pressure Hydrocephalus
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Questionable Seizure
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Self Limited Tremor Of Head & Left Upper Limb, 1
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Syncope, Confusion, Light Headedness
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Vertigo/Headache
|
0.62%
1/161 • 5 years
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.62%
1/161 • 5 years
|
|
Product Issues
Device Fracture
|
2.5%
4/161 • 5 years
|
|
Product Issues
Indeterminate
|
0.62%
1/161 • 5 years
|
|
Product Issues
Type II Endoleak
|
51.6%
83/161 • 5 years
|
|
Product Issues
Type IA (Proximal)
|
1.2%
2/161 • 5 years
|
|
Product Issues
Type IIIA (Disconnectino/Disjunction)
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Anxiety
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Dementia
|
1.9%
3/161 • 5 years
|
|
Psychiatric disorders
Increasing Memory Loss
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Mental Status Changes
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Mild Confusion
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Worsening Anxiety
|
0.62%
1/161 • 5 years
|
|
Psychiatric disorders
Worsening Depression
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Renal Failure
|
1.9%
3/161 • 5 years
|
|
Renal and urinary disorders
Acute Kidney Injury With High Potassium
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Bladder Dome Mucosal Nodule
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Bph
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Cystitis
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
1.9%
3/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bilateral Hernia Inguinal Hernia Repair
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bilateral Inguinal Hernias
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis Olecrani Right Side
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Compression Injury Upper Thoracic Spine Vertebra
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Dental Caries With Lip Ulcer
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Exacerbation Of Degenerative Joint Disease
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Inguinal Hernia
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Left Inguinal Hernia
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spondylosis, Lumbar Facet Arthropathy
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal- Myalgias
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain Upper Leg And Sural Muscle
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Right Inguinal Hernia Incarceration
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Right Knee/Calf Numbness
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Sprained Left Wrist/Inflammatory Arthritis
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
T12 compression fracture
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Rt knee pain, torn tissue
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Rt achilles injury/tear
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Rt hip pain
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Rt knee pain- arthritis
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Acute Synovitis
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Advanced Tooth Carie With Acute Pain
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
5/161 • 5 years
|
|
Blood and lymphatic system disorders
Anemia Due To B12 Deficiency
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Anemia-Low Hemoglobin And Hematocrit
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Anemia-Macrocytic
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Decreased Hematocrit Level
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Elevated Inr Levels
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Elevated Wbc
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.9%
3/161 • 5 years
|
|
Blood and lymphatic system disorders
N2- Worsening Of Anemia Post Op
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Supratherapeutic Inr 8.6
|
0.62%
1/161 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Angina
|
4.3%
7/161 • 5 years
|
|
Cardiac disorders
Arrhythmia
|
2.5%
4/161 • 5 years
|
|
Cardiac disorders
Congestive Heart Failure
|
3.1%
5/161 • 5 years
|
|
Cardiac disorders
Acute Congestive Heart Failure
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Afib With Rapid Ventricular Response
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Apical Thrombus
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Asymptomatic Pvc's During Routine Colonoscopy
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Atrial Septal Aneurysm
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Bradycardia
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Decreased Ef From 35% To 25%
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
High Pulse Rate- Tachycardia
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Increase Troponin Levels
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Irregular Heart Beat
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Pericardial Effusion
|
0.62%
1/161 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.62%
1/161 • 5 years
|
|
Congenital, familial and genetic disorders
Pfo
|
0.62%
1/161 • 5 years
|
|
Ear and labyrinth disorders
Hearing Loss
|
0.62%
1/161 • 5 years
|
|
Ear and labyrinth disorders
Hearing Loss Left Ear
|
0.62%
1/161 • 5 years
|
|
Ear and labyrinth disorders
Otitis Media/Hearing Loss
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Diabetes
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Diabetic Ketacedosis
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Elevated Tsh
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Exacerbation Of Type Ii Diabetes
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Hypothyroidism
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Increased Glucose Level
|
0.62%
1/161 • 5 years
|
|
Endocrine disorders
Positive Ketones In Urine
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Blurred Vision R Eye
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Ambulatory Elective Cataract Op
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Bruised Left Eye
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Cataract In Left Eye
|
1.2%
2/161 • 5 years
|
|
Eye disorders
Cataract Phacoemulsification Of The Left Eye.
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Cataract Phacoemulsification Of The Right Eye
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Conjunctivitis
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Conjunctivitis Right Eye
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Incisional Biopsy Of Left Upper Eyelid
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Macular Degeneration
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Occular Rosacea
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Removal Of Cataracts
|
0.62%
1/161 • 5 years
|
|
Eye disorders
Cataract Right Eye
|
1.9%
3/161 • 5 years
|
|
Gastrointestinal disorders
Adynamic ileus
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
"stomach Gnawing"
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Ascites
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Barrett's Esophagus
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Barrett's High Grade Dysplasia
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Blood In Stool
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Bloody Stools
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Cholitis With Urinary Retention And Rectal Urgen
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Colon Polyp
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
2.5%
4/161 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Diverticulosis
|
2.5%
4/161 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
3/161 • 5 years
|
|
Gastrointestinal disorders
Esophageal Spasm
|
1.2%
2/161 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.5%
4/161 • 5 years
|
|
Gastrointestinal disorders
Gi Bleeding With Esophagil Varicosis
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Hematemesis
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Irregular Bowel Movements
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
1.9%
3/161 • 5 years
|
|
Gastrointestinal disorders
Nausea And Vomiting. Etiology
|
1.2%
2/161 • 5 years
|
|
Gastrointestinal disorders
Pancreatic Head Lesion
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Sigma Diverticulosis
|
1.2%
2/161 • 5 years
|
|
Gastrointestinal disorders
Upper Gi Bleed
|
0.62%
1/161 • 5 years
|
|
Gastrointestinal disorders
Upper Gi Endoscopy - Multiple Thermal Ablation O
|
0.62%
1/161 • 5 years
|
|
General disorders
Fever
|
2.5%
4/161 • 5 years
|
|
General disorders
1+ Edema Bilat Lower Extremities
|
0.62%
1/161 • 5 years
|
|
General disorders
1+ Pitting Edema
|
0.62%
1/161 • 5 years
|
|
General disorders
Abdominal Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Allergic Reaction To Klonopin
|
0.62%
1/161 • 5 years
|
|
General disorders
Arm Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Atypical Chest Pain. All Cardiac Diagnostic -Neg
|
0.62%
1/161 • 5 years
|
|
General disorders
Back Pain
|
3.1%
5/161 • 5 years
|
|
General disorders
Bilateral Leg Fatigue
|
0.62%
1/161 • 5 years
|
|
General disorders
Bilateral Lower Extremity Edema
|
1.9%
3/161 • 5 years
|
|
General disorders
Bilateral Lower Leg Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Bruising Of Right Upper Arm
|
0.62%
1/161 • 5 years
|
|
General disorders
Burning Feeling In Chest
|
0.62%
1/161 • 5 years
|
|
General disorders
C/O Hip Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Calf Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Chest And Back Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Chest Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Chest Pressure
|
0.62%
1/161 • 5 years
|
|
General disorders
Deconditioning
|
0.62%
1/161 • 5 years
|
|
General disorders
Difficulty Sleeping
|
0.62%
1/161 • 5 years
|
|
General disorders
Dizziness
|
1.9%
3/161 • 5 years
|
|
General disorders
Epistaxis
|
1.2%
2/161 • 5 years
|
|
General disorders
Fall At Home
|
1.9%
3/161 • 5 years
|
|
General disorders
False Aneurysma Right Inguinal Side
|
0.62%
1/161 • 5 years
|
|
General disorders
Fatigue
|
1.2%
2/161 • 5 years
|
|
General disorders
Groin Pain
|
1.2%
2/161 • 5 years
|
|
General disorders
Heache/Nausea
|
1.2%
2/161 • 5 years
|
|
General disorders
Increasingly Swollen Lower Extremities
|
0.62%
1/161 • 5 years
|
|
General disorders
Intermittent Groin Pain
|
1.9%
3/161 • 5 years
|
|
General disorders
Intractable Hiccups
|
0.62%
1/161 • 5 years
|
|
General disorders
Laceration Left Thumb
|
0.62%
1/161 • 5 years
|
|
General disorders
Left Flank Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Left Leg Swelling
|
0.62%
1/161 • 5 years
|
|
General disorders
Left Lower Extremity Edema
|
0.62%
1/161 • 5 years
|
|
General disorders
Left Lower Leg And Ankle 2+ Pitting Edema
|
0.62%
1/161 • 5 years
|
|
General disorders
Legs Feel "rubbery"
|
0.62%
1/161 • 5 years
|
|
General disorders
Lower Back And Leg Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Malaise- General
|
0.62%
1/161 • 5 years
|
|
General disorders
N2: Pain In Both Inguinal
|
0.62%
1/161 • 5 years
|
|
General disorders
Nausea
|
0.62%
1/161 • 5 years
|
|
General disorders
Night Sweats
|
0.62%
1/161 • 5 years
|
|
General disorders
Pain In Kidney Area
|
0.62%
1/161 • 5 years
|
|
General disorders
Pain In The Right Upper Quadrant Of Abdomen
|
0.62%
1/161 • 5 years
|
|
General disorders
Patient Went To Er For Abdominal Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Poor Sleep
|
0.62%
1/161 • 5 years
|
|
General disorders
Progressive Lower Limb Weakness
|
0.62%
1/161 • 5 years
|
|
General disorders
Psa-Values Increased
|
0.62%
1/161 • 5 years
|
|
General disorders
Right Ear Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Right Flank Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Right Groin Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Right Hip Pain
|
1.2%
2/161 • 5 years
|
|
General disorders
Right Side Stitch
|
0.62%
1/161 • 5 years
|
|
General disorders
Right Upper Quadrant Abdominal Pain
|
0.62%
1/161 • 5 years
|
|
General disorders
Rt Groin Site Swollen And Burning With Hard Lump
|
0.62%
1/161 • 5 years
|
|
General disorders
Sob While Walking
|
0.62%
1/161 • 5 years
|
|
General disorders
Soreness In Chest
|
0.62%
1/161 • 5 years
|
|
General disorders
Syncope
|
1.2%
2/161 • 5 years
|
|
General disorders
Weakness
|
0.62%
1/161 • 5 years
|
|
General disorders
Worsening Of Lower Extremity Edema
|
0.62%
1/161 • 5 years
|
|
General disorders
Worsening of Restless Leg Syndrome
|
0.62%
1/161 • 5 years
|
|
General disorders
Wound Discomfort
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Infection (other than wound)
|
8.7%
14/161 • 5 years
|
|
Infections and infestations
Cellulitis Left Lower Extremity
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Helicobacter Pylori
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Mrsa Bacteremia
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
N2- Herpes Zoster With Postherpetic Neuralgia
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Recurrent Left Lower Extremity Cellulitis
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Right Lower Extremity Infection
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Shingles
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Sinus Infection
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Subclinical Shingles Outbreak
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Tooth Absess
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Urinary Tract Infection Due To Chronic Indwelling Foley Catheter
|
0.62%
1/161 • 5 years
|
|
Infections and infestations
Wound Infection
|
1.9%
3/161 • 5 years
|
|
Metabolism and nutrition disorders
Calcium Level Remains Below Normal At 8.2
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/161 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.2%
2/161 • 5 years
|
|
Metabolism and nutrition disorders
Low Vitamin D
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Paraproteinemia Protein 10.2
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Protein Malnutrition
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Unintentional Weight Loss
|
0.62%
1/161 • 5 years
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
4/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Injection
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel sundrome
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
DDD lower spine
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Foot drop
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Lt. knee pain
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.62%
1/161 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain Shoulder
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Worsening Renal Insufficiency
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Worsening Renal Insufficiency Ckd Stage III
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Worsening Renal Insufficiency Ckd Stage IV
|
0.62%
1/161 • 5 years
|
|
Renal and urinary disorders
Urinary Retention
|
2.5%
4/161 • 5 years
|
|
Reproductive system and breast disorders
Impotence
|
0.62%
1/161 • 5 years
|
|
Reproductive system and breast disorders
Right Spermocele
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.7%
6/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.2%
2/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
1.2%
2/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Sinusitis, Maxillary
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonitis
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bibasilar Atelectasis
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Pleural Effusions
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.5%
4/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Centrilobular And Paraseptal Emphysema
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Copd
|
1.9%
3/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Copd Exacerbation
|
1.2%
2/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
3/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
6/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Emphysematous Changes In Lungs
|
1.2%
2/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbated Chronic Obstructive Pulmonary Disease
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Focal Bronciolitis
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia And Copd Exacerbation
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Left Pleural Effusion
|
1.2%
2/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
New 5 Mm Nodule Right Lower Lobe, Nonspecific
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-Cardiac Pleuritic Pain
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-Productive Cough
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Chest Pain
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough With Yellow Sputum
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis- Amiodarone Related
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Nodules
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Right Pleual Effusion
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Short Of Breath
|
1.9%
3/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Small Right Pleural Effusion
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
sob
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Lobe Infiltrate
|
0.62%
1/161 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Anterior Ankle Ulcer
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Bilat Feet Non-Healing Sores
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema Over Doral Aspect Of Left Foot
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Fall With Facial Abrasions
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Laceration Of Small Right Toe
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Left Foot Ulcer
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Lipoma Excision
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Mild Wound Ecchymosis
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Petechial Rash On Shins Related To Chemotherapy
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
2/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Sebaceous Cyst Right Posterior Neck
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Biopsies
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Integrity
|
0.62%
1/161 • 5 years
|
|
Skin and subcutaneous tissue disorders
Suspect Birthmark
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Intraoperative Bleeding
|
5.0%
8/161 • 5 years
|
|
Surgical and medical procedures
Lymphocele/Lymphatic Fistula
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Acute Blood Loss Anemia Following Orif
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Bilateral Groin Erythema
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Cr 1.7. Ct Was Done W/O Contrast and Ultrasound
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Erythema Around Groin Incision
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Incisional Hernia After Nephrectomia
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Iv Dye Reaction
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Pain Over Acid
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Post Operative Anemia
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Post-Operative Incisional Pain
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Prolonged Intubation Because Of Anesthesia
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Reaction During Ct Scan
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Right Groin 1mm Opening
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Vancomycin Toxicity
|
0.62%
1/161 • 5 years
|
|
Surgical and medical procedures
Slight Reaction To Contrast Medium
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Aneurysm enlargement
|
3.7%
6/161 • 5 years
|
|
Vascular disorders
Aortic Body Stenosis
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.2%
2/161 • 5 years
|
|
Vascular disorders
Dissection
|
1.2%
2/161 • 5 years
|
|
Vascular disorders
Hypertension
|
3.7%
6/161 • 5 years
|
|
Vascular disorders
Hypotension
|
6.2%
10/161 • 5 years
|
|
Vascular disorders
Peripheral Ischemia
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Aneurysm Enlargement
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Celiac Artery Stenosis
|
1.2%
2/161 • 5 years
|
|
Vascular disorders
Dissection Of Right External Iliac Artery
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Dvt
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Left Carotid Artery Stenosis
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Left Iliac Limb Stenosis
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Left Renal Artery Calcified Plaque
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Left Renal Artery Stenosis
|
1.2%
2/161 • 5 years
|
|
Vascular disorders
Malfunctioning Valves In Right Great Saphenous V
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Multiple Peripheral Cns Emboli
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Obstruction Of Illiac Arteries Without Symptoms
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Petechial Hemorrhage
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Progression Of Pvd Stenosis Left External Iliac
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Right Carotid Stenosis
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Right Common Femoral Artery Aneurysm
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Right Renal Artery Stenosis
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
S/P Taa Endorepair Now With Type Ii Endoleak
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Small Ascending Thoracic Aneurysm
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Stenosis Right Renal Artery
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Superficial Acute Thrombophlebitis
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Superficial Phlebitis L Upper Extremity
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Thoracic Aortic Aneurysm
|
1.2%
2/161 • 5 years
|
|
Vascular disorders
Uncontrolled Hypertension
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Worsening Claudication
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Worsening Hypertension
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Vascular Occlusion
|
0.62%
1/161 • 5 years
|
|
Vascular disorders
Left Upper Lip Laceration
|
0.62%
1/161 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER