Trial Outcomes & Findings for ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation (NCT NCT01694563)

NCT ID: NCT01694563

Last Updated: 2019-10-09

Results Overview

The number of participants free from atrial fibrillation (AF), i.e., episodes lasting \>30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 365 participants
• Primary outcome timeframe: 36 months post-operatively
• Results posted on: 2019-10-09

Participant Flow

Subjects were enrolled from: September 2012 thru October 2017

Participant milestones

Measure	Atrial Fibrillation Subjects enrolled exhibited the following types of Atrial fibrillation: Non-Paroxysmal, Persistent, and Long-Standing Persistent
Overall Study STARTED	365
Overall Study COMPLETED	278
Overall Study NOT COMPLETED	87

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation

Baseline characteristics by cohort

Measure	Atrial Fibrillation n=365 Participants Patients with non-paroxysmal atrial fibrillation (persistent or longstanding persistent)who are scheduled to undergo elective concomitant open, on-pump cardiac surgical procedure and the Maze IV ablation procedure. This single arm registry is designed to monitor the AtriCure Synergy Ablation System for continued safety and efficacy during the peri-procedural and long term phase during commercial use. Synergy Ablation System: Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following: * Coronary Artery Bypass Grafting (CABG) * Mitral valve repair or replacement * Aortic valve repair or replacement * Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria.
Age, Continuous	69.8 years n=5 Participants
Sex: Female, Male Female	148 Participants n=5 Participants
Sex: Female, Male Male	217 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	17 Participants n=5 Participants
Race (NIH/OMB) White	331 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants
Region of Enrollment United States	365 participants n=5 Participants
History of Arrhythmia	365 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months post-operatively

Population: Freedom from AF and off antiarrhythmic drugs (AADs) at specific time points. The participants that met the endpoint are reflected in the Outcome Measure Data Table.

The number of participants free from atrial fibrillation (AF), i.e., episodes lasting >30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.

Outcome measures

Measure	36 Months Post-operatively n=232 Participants The primary effectiveness outcome is defined as the proportion of patients free from AF (i.e. no episodes lasting \> 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) while off Class I and III antiarrhythmic drugs for at least 4 weeks as determined by an independent core lab assessment of 48 hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 36 months postoperatively.	24 Months Post-operatively Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.	36 Months Post-operatively Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.
The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks.	146 Participants	—	—

SECONDARY outcome

Timeframe: 12, 24, and 36 months post-operatively

Population: Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage. The participants that met the endpoint are reflected in the Outcome Measure Data Table.

The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting > 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), as determined by an independent core lab assessment of 48-hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 12,24, and 36 months post-operatively.

Outcome measures

Measure	36 Months Post-operatively n=271 Participants The primary effectiveness outcome is defined as the proportion of patients free from AF (i.e. no episodes lasting \> 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) while off Class I and III antiarrhythmic drugs for at least 4 weeks as determined by an independent core lab assessment of 48 hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 36 months postoperatively.	24 Months Post-operatively n=242 Participants Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.	36 Months Post-operatively n=228 Participants Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.
Secondary Efficacy Outcome	216 Participants	187 Participants	168 Participants

Adverse Events

Treatment Arm

Serious events: 289 serious events

Other events: 271 other events

Deaths: 20 deaths

Serious adverse events

Measure	Treatment Arm n=365 participants at risk Patients with non-paroxysmal atrial fibrillation ………..
Cardiac disorders Tricuspid valve incompetence	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Bradycardia	5.5% 20/365 • Number of events 20 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Ventricular Tachycardia	2.5% 9/365 • Number of events 9 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Venous Injury	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Haemorrhage	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Death	5.5% 20/365 • Number of events 20 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Abdominal Hernia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Blood and lymphatic system disorders Anemia	4.4% 16/365 • Number of events 16 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Blood and lymphatic system disorders Coagulopathy	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Blood and lymphatic system disorders Thrombocytopenia	1.4% 5/365 • Number of events 5 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Blood and lymphatic system disorders Leukocytosis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Angina unstable	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Aortic Valve Incompetence	1.4% 5/365 • Number of events 5 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Arrythmia	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Atrial Fibrillation	12.3% 45/365 • Number of events 45 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Atrial Flutter	4.7% 17/365 • Number of events 17 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Atrial Rupture	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Atrial Tachycardia	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Atrioventricular Block	6.6% 24/365 • Number of events 24 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Cardiac Arrest	1.6% 6/365 • Number of events 6 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Cardiac Failure	24.7% 90/365 • Number of events 90 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Cardiac Tamponade	1.4% 5/365 • Number of events 5 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Cardiogenic Shock	3.8% 14/365 • Number of events 14 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Cardiorenal Syndrome	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Cardio-respiratory Arrest	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Chest Pain	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Complete Heart Block	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Coronary Artery Occlusion	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Coronary Artery Stenosis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Heart Valve Incompetence	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Ischaemic cardiomyopathy	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Left ventricular dysfunction	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Mitral Valve Disease	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Mitral Valve incompetence	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Mitral Valve stenosis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Myocardial Infarction	2.5% 9/365 • Number of events 9 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Nodal Rhythm	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Pericardial effusion	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Right ventricular failure	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Sick sinus syndrome	7.9% 29/365 • Number of events 29 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Ventricular asystole	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Ventricular fibrillation	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Ventricular dysfunction	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Cardiac disorders Ventricular tachycardia	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Congenital, familial and genetic disorders Left ventricular outflow tract obstruction	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Abdominal mass	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Abdominal pain	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Ascites	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Colitis	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Colonic pseudo obstruction	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Diarrhoea	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Duodenal ulcer	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Gastrointestinal hemorrhage	4.1% 15/365 • Number of events 15 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Haematochezia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Hiatus hernia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Ileus	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Intestinal obstruction	1.6% 6/365 • Number of events 6 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Intestinal perforation	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Intra-abdominal haematoma	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Pancreatitis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Rectal hemorrhage	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Umbilical hernia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Adverse drug reaction	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Asthenia	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Chest pain	3.8% 14/365 • Number of events 14 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Gait disturbance	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Multi-organ failure	1.6% 6/365 • Number of events 6 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Oedema peripheral	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Pyrexia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Sudden death	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
General disorders Ulcer	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Hepatobiliary disorders Cholecystitis	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Hepatobiliary disorders Hepatic failure	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Hepatobiliary disorders Porcelain gallbladder	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Appendicitis	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Bacteraemia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Bronchitis	1.4% 5/365 • Number of events 5 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Cellulitis	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Central line infection	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Clostridium difficile colitis	1.9% 7/365 • Number of events 7 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Diverticlitis	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Empyema	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Endocarditis	1.4% 5/365 • Number of events 5 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Enterococcal infection	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Gangrene	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Graft infection	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Groin infection	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Herpes zoster	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Implant site infection	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Infection	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Influenza	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Osteomyelitis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Pneumonia	9.9% 36/365 • Number of events 36 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Wound infection	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Sepsis	4.9% 18/365 • Number of events 18 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Septic shock	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Staphylococcal infection	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Urinary tract infection	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Alcohol poisoning	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Contusion	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Fall	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Femur fracture	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Hepatic haematoma	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Hip fracture	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Joint dislocation	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Nerve injury	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Post procedural thoracic complication	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Traffic accident	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Subdural haemotoma	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Tibia fracture	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Tracheostomy malfunction	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Vena cava injury	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Venous injury	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Injury, poisoning and procedural complications Wound dehiscence	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Investigations Blood creatinine increased	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Investigations International normalised ratio increased	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Dehydration	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Electrolyte imbalance	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Fluid overload	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Gout	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Hyperglycemia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Hyperkalaemia	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Hypoglycemia	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Hypokalaemia	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Hyponatraemia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Metabolism and nutrition disorders Malnutrition	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Arthritis	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Back pain	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Joint swelling	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Decreased mobility	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Osterarthritis	2.2% 8/365 • Number of events 8 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Anoxic encephalopothy	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Aphasia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Coratid artery stenosis	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Cerebral hemorrhage	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Cerebrovascular accident	3.6% 13/365 • Number of events 13 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Dementia	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Diabetic neuropathy	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Embolic stroke	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Encephalopathy	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Facial paresis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Hemianopia homonymous	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Ischaemic stroke	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Loss of consciousness	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Metabolic encephalopathy	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Migraine	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Subarachnoid haemorrhage	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Syncope	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Nervous system disorders Transient ischaemic attack	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Psychiatric disorders Alcohol abuse	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Psychiatric disorders Alcohol withdrawal syndrome	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Psychiatric disorders Anorexia nervosa	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Psychiatric disorders Delirium	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Psychiatric disorders Mental status changes	1.4% 5/365 • Number of events 5 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Renal and urinary disorders Haematuria	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Renal and urinary disorders Hydronephrosis	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Renal and urinary disorders Renal failure	8.8% 32/365 • Number of events 32 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Renal and urinary disorders Renal tubular necrosis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Renal and urinary disorders Urinary retention	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.2% 8/365 • Number of events 8 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.6% 13/365 • Number of events 13 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Mediastinal haematoma	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.0% 40/365 • Number of events 40 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.4% 5/365 • Number of events 5 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary vein stenosis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	17.8% 65/365 • Number of events 65 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Skin and subcutaneous tissue disorders Blister	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Surgical and medical procedures Cardiac pacemaker revision	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Surgical and medical procedures Carotid endarterectomy	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Surgical and medical procedures Hip arthroplasty	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Surgical and medical procedures Knee arthroplasty	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Surgical and medical procedures Mitral valve replacement	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Surgical and medical procedures Vertebroplasty	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Aortic stenosis	0.55% 2/365 • Number of events 2 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Arterial insufficiency	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Arteriosclerosis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Artery dissection	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Deep vein thrombosis	1.1% 4/365 • Number of events 4 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Femoral arterial stenosis	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Haematoma	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Haemorrhage	5.2% 19/365 • Number of events 19 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Hypertension	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Hypotension	3.6% 13/365 • Number of events 13 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Peripheral vascular disorder	0.82% 3/365 • Number of events 3 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Shock haemorrhagic	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Gastrointestinal disorders Constipation	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.27% 1/365 • Number of events 1 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.

Other adverse events

Measure	Treatment Arm n=365 participants at risk Patients with non-paroxysmal atrial fibrillation ………..
Blood and lymphatic system disorders Aenemia	6.0% 22/365 • Number of events 22 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Vascular disorders Hypotension	7.4% 27/365 • Number of events 30 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	16.2% 59/365 • Number of events 59 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	8.5% 31/365 • Number of events 31 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Renal and urinary disorders Renal Failure	13.2% 48/365 • Number of events 48 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Infections and infestations Pneumonia	6.0% 22/365 • Number of events 22 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 26/365 • Number of events 28 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Renal and urinary disorders Urinary Tract Infection	10.4% 38/365 • Number of events 42 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.
Respiratory, thoracic and mediastinal disorders Bronchitis	5.8% 21/365 • Number of events 21 • All adverse events were collected for 36 months. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.

Additional Information

Nfii K. Ndikintum, PhD, MBA / VP, Clinical Affairs and Biometrics

Atricure Inc.

Phone: 513-644-8192

Email: NNdikintum@atricure.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place