Trial Outcomes & Findings for Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology (NCT NCT02702271)
NCT ID: NCT02702271
Last Updated: 2022-06-14
Results Overview
The occurrence of one of the following events : all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are captured as adverse events (AEs), and are excluded from this endpoint.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
458 participants
Primary outcome timeframe
events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later
Results posted on
2022-06-14
Participant Flow
Participant milestones
| Measure |
WATCHMAN FLX - M
Main Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
WATCHMAN FLX - R
Roll-In Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
|---|---|---|
|
Overall Study
STARTED
|
400
|
58
|
|
Overall Study
COMPLETED
|
337
|
49
|
|
Overall Study
NOT COMPLETED
|
63
|
9
|
Reasons for withdrawal
| Measure |
WATCHMAN FLX - M
Main Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
WATCHMAN FLX - R
Roll-In Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
|---|---|---|
|
Overall Study
Death
|
36
|
7
|
|
Overall Study
Lost to Follow-up
|
12
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Unsuccessful Implant Attempt
|
5
|
1
|
Baseline Characteristics
Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
Baseline characteristics by cohort
| Measure |
WATCHMAN FLX - M
n=400 Participants
Main Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
WATCHMAN FLX - R
n=58 Participants
Roll-In Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
345 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
75.2 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
74.0 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
390 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
448 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
358 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
400 participants
n=5 Participants
|
58 participants
n=7 Participants
|
458 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is laterThe occurrence of one of the following events : all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are captured as adverse events (AEs), and are excluded from this endpoint.
Outcome measures
| Measure |
WATCHMAN FLX - M
n=400 Participants
Main Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
WATCHMAN FLX - R
n=58 Participants
Roll-In Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
|---|---|---|
|
Number of Participants With a Safety Event
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: The Primary Effectiveness Endpoint is the rate of effective LAA closure at 12 months (defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE). The overall number of participants analyzed (342 in main and 52 in roll-in cohort) are the number of participants who had evaluable 12 month core lab f/u data from the total number of participants enrolled.
The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months.
Outcome measures
| Measure |
WATCHMAN FLX - M
n=342 Participants
Main Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
WATCHMAN FLX - R
n=52 Participants
Roll-In Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
|---|---|---|
|
Number of Participants With Effective LAA Closure
|
342 Participants
|
52 Participants
|
Adverse Events
WATCHMAN FLX - M
Serious events: 157 serious events
Other events: 96 other events
Deaths: 36 deaths
WATCHMAN FLX - R
Serious events: 25 serious events
Other events: 15 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
WATCHMAN FLX - M
n=400 participants at risk
Main Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
WATCHMAN FLX - R
n=58 participants at risk
Roll-In Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
11/400 • Number of events 13 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.75%
3/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Angina pectoris
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Angina unstable
|
0.25%
1/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
9.0%
36/400 • Number of events 38 • Adverse events that occur through 24 months post procedure.
|
5.2%
3/58 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Atrial flutter
|
1.8%
7/400 • Number of events 8 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Atrial tachycardia
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Bradycardia
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Cardiac arrest
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Cardiac failure
|
1.2%
5/400 • Number of events 6 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Cardiac failure acute
|
1.8%
7/400 • Number of events 7 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.8%
15/400 • Number of events 22 • Adverse events that occur through 24 months post procedure.
|
10.3%
6/58 • Number of events 6 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Cardiogenic shock
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Cardiomyopathy
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
6/400 • Number of events 6 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
3.4%
2/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
8/400 • Number of events 9 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Pericarditis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Colitis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Gastritis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.8%
15/400 • Number of events 16 • Adverse events that occur through 24 months post procedure.
|
13.8%
8/58 • Number of events 9 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Haematochezia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Melaena
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Odynophagia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Asthenia
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Catheter site haematoma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Chest discomfort
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Chest pain
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Death
|
1.2%
5/400 • Number of events 5 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Device related thrombosis
|
1.5%
6/400 • Number of events 6 • Adverse events that occur through 24 months post procedure.
|
3.4%
2/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Generalised oedema
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Hernia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Incarcerated hernia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Multimorbidity
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Non-cardiac chest pain
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Pyrexia
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Ulcer haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Hepatobiliary disorders
Cholangitis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Appendicitis
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Arthritis infective
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Bacterial sepsis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Bronchitis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Cellulitis
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Corona virus infection
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Diverticulitis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Gastroenteritis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Influenza
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Kidney infection
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Nocardiosis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Osteomyelitis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Pancreatic abscess
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Perinephric abscess
|
0.25%
1/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Pneumonia
|
4.5%
18/400 • Number of events 19 • Adverse events that occur through 24 months post procedure.
|
6.9%
4/58 • Number of events 5 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Respiratory tract infection
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Sepsis
|
2.5%
10/400 • Number of events 11 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Septic shock
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Subacute endocarditis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
5/400 • Number of events 5 • Adverse events that occur through 24 months post procedure.
|
3.4%
2/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Wound infection
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Fall
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Injury
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Investigations
Influenza A virus test positive
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Investigations
Influenza B virus test positive
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
2/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
8/400 • Number of events 9 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma metastatic
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Cerebral infarction
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
4/400 • Number of events 5 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Dizziness
|
0.25%
1/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Embolic stroke
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Encephalopathy
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Hydrocephalus
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Presyncope
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Seizure
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Syncope
|
1.2%
5/400 • Number of events 5 • Adverse events that occur through 24 months post procedure.
|
6.9%
4/58 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
Product Issues
Device leakage
|
2.5%
10/400 • Number of events 12 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Product Issues
Lead dislodgement
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Psychiatric disorders
Delirium
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Psychiatric disorders
Depression
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Psychiatric disorders
Mental status changes
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
8/400 • Number of events 8 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
End stage renal disease
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Haematuria
|
1.0%
4/400 • Number of events 6 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Renal failure
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Renal pain
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Urinary retention
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.8%
7/400 • Number of events 7 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
3.4%
2/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
5/400 • Number of events 6 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Rheumatoid lung
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Accelerated hypertension
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
3.4%
2/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Haematoma
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Hypotension
|
1.2%
5/400 • Number of events 5 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Orthostatic hypotension
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
Other adverse events
| Measure |
WATCHMAN FLX - M
n=400 participants at risk
Main Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
WATCHMAN FLX - R
n=58 participants at risk
Roll-In Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
5/400 • Number of events 5 • Adverse events that occur through 24 months post procedure.
|
3.4%
2/58 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Atrial flutter
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Atrial septal defect acquired
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Bradycardia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Cardiac steatosis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
10/400 • Number of events 10 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Congenital, familial and genetic disorders
Congenital oesophageal anomaly
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Eye disorders
Eye haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Eye disorders
Ocular hyperaemia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Eye disorders
Retinal haemorrhage
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Haematochezia
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
3.4%
2/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
5.2%
3/58 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Tongue haematoma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Cardiac complication associated with device
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Catheter site bruise
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
3.4%
2/58 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Catheter site haematoma
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Catheter site haemorrhage
|
1.8%
7/400 • Number of events 7 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Catheter site vesicles
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
General disorders
Chest discomfort
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Infections and infestations
Urinary tract infection
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Cardiac septal defect residual shunt
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.5%
14/400 • Number of events 16 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.75%
3/400 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.0%
4/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Subarachnoid haematoma
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/400 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Headache
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Ischaemic stroke
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Product Issues
Device leakage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Haematuria
|
1.8%
7/400 • Number of events 8 • Adverse events that occur through 24 months post procedure.
|
5.2%
3/58 • Number of events 3 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Renal and urinary disorders
Urinary retention
|
0.50%
2/400 • Number of events 2 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
18/400 • Number of events 18 • Adverse events that occur through 24 months post procedure.
|
6.9%
4/58 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.75%
3/400 • Number of events 4 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.5%
6/400 • Number of events 6 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Haematoma
|
1.2%
5/400 • Number of events 6 • Adverse events that occur through 24 months post procedure.
|
1.7%
1/58 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Haemorrhage
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Hypertension
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
|
Vascular disorders
Hypotension
|
0.25%
1/400 • Number of events 1 • Adverse events that occur through 24 months post procedure.
|
0.00%
0/58 • Adverse events that occur through 24 months post procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place