Trial Outcomes & Findings for PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement (NCT NCT04149535)

NCT ID: NCT04149535

Last Updated: 2023-02-02

Results Overview

All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3000 participants
• Primary outcome timeframe: <=72 hours
• Results posted on: 2023-02-02

Participant Flow

Participant milestones

Measure	TAVR With Sentinel Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Sentinel® Cerebral Protection System: cerebral embolic protection system	TAVR Without Sentinel Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
Overall Study STARTED	1501	1499
Overall Study COMPLETED	1472	1481
Overall Study NOT COMPLETED	29	18

Reasons for withdrawal

Measure	TAVR With Sentinel Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Sentinel® Cerebral Protection System: cerebral embolic protection system	TAVR Without Sentinel Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
Overall Study Death	11	7
Overall Study Physician Decision	10	4
Overall Study Withdrawal by Subject	6	7
Overall Study Not described	2	0

Baseline Characteristics

Data not collected on patients from EU.

Baseline characteristics by cohort

Measure	TAVR With Sentinel n=1501 Participants Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Sentinel® Cerebral Protection System: cerebral embolic protection system	TAVR Without Sentinel n=1499 Participants Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.	Total n=3000 Participants Total of all reporting groups
Age, Continuous	78.9 years STANDARD_DEVIATION 8.0 • n=1501 Participants	78.9 years STANDARD_DEVIATION 7.8 • n=1499 Participants	78.9 years STANDARD_DEVIATION 7.9 • n=3000 Participants
Sex: Female, Male Female	631 Participants n=1501 Participants	566 Participants n=1499 Participants	1197 Participants n=3000 Participants
Sex: Female, Male Male	870 Participants n=1501 Participants	933 Participants n=1499 Participants	1803 Participants n=3000 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participants n=961 Participants • Data not collected on patients from EU.	3 Participants n=963 Participants • Data not collected on patients from EU.	8 Participants n=1924 Participants • Data not collected on patients from EU.
Race/Ethnicity, Customized Asian	14 Participants n=961 Participants • Data not collected on patients from EU.	16 Participants n=963 Participants • Data not collected on patients from EU.	30 Participants n=1924 Participants • Data not collected on patients from EU.
Race/Ethnicity, Customized Black or African Heritage	31 Participants n=961 Participants • Data not collected on patients from EU.	25 Participants n=963 Participants • Data not collected on patients from EU.	56 Participants n=1924 Participants • Data not collected on patients from EU.
Race/Ethnicity, Customized Caucasian	852 Participants n=961 Participants • Data not collected on patients from EU.	872 Participants n=963 Participants • Data not collected on patients from EU.	1724 Participants n=1924 Participants • Data not collected on patients from EU.
Race/Ethnicity, Customized Hispanic or Latino	53 Participants n=961 Participants • Data not collected on patients from EU.	35 Participants n=963 Participants • Data not collected on patients from EU.	88 Participants n=1924 Participants • Data not collected on patients from EU.
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=961 Participants • Data not collected on patients from EU.	0 Participants n=963 Participants • Data not collected on patients from EU.	1 Participants n=1924 Participants • Data not collected on patients from EU.
Race/Ethnicity, Customized Other	12 Participants n=961 Participants • Data not collected on patients from EU.	13 Participants n=963 Participants • Data not collected on patients from EU.	25 Participants n=1924 Participants • Data not collected on patients from EU.
Race/Ethnicity, Customized Not Disclosed	11 Participants n=961 Participants • Data not collected on patients from EU.	11 Participants n=963 Participants • Data not collected on patients from EU.	22 Participants n=1924 Participants • Data not collected on patients from EU.
Surgical Risk (Per Heart Team): Extreme/High Risk	457 Participants n=1501 Participants	456 Participants n=1499 Participants	913 Participants n=3000 Participants
Surgical Risk (Per Heart Team): Intermediate Risk	499 Participants n=1501 Participants	512 Participants n=1499 Participants	1011 Participants n=3000 Participants
Surgical Risk (Per Heart Team): Low Risk	545 Participants n=1501 Participants	531 Participants n=1499 Participants	1076 Participants n=3000 Participants
Native/Non-Native Valve Calcification Severity (site reported): None/Mild	241 Participants n=1501 Participants	223 Participants n=1499 Participants	464 Participants n=3000 Participants
Native/Non-Native Valve Calcification Severity (site reported): Moderate	418 Participants n=1501 Participants	426 Participants n=1499 Participants	844 Participants n=3000 Participants
Native/Non-Native Calcification Severity (site reported): Severe/Extreme	773 Participants n=1501 Participants	792 Participants n=1499 Participants	1565 Participants n=3000 Participants

PRIMARY outcome

Timeframe: <=72 hours

Population: Intent-to-Treat

All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.

Outcome measures

Measure	TAVR With Sentinel n=1501 Participants Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Sentinel® Cerebral Protection System: cerebral embolic protection system	TAVR Without Sentinel n=1499 Participants Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	34 Participants	43 Participants

Adverse Events

TAVR With Sentinel

Serious events: 285 serious events

Other events: 0 other events

Deaths: 11 deaths

TAVR Without Sentinel

Serious events: 315 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Measure	TAVR With Sentinel n=1501 participants at risk Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Sentinel® Cerebral Protection System: cerebral embolic protection system	TAVR Without Sentinel n=1499 participants at risk Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
Metabolism and nutrition disorders Fluid overload	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Metabolism and nutrition disorders Hyperkalaemia	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Atrioventricular block complete	5.7% 86/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	6.1% 92/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Bundle branch block left	2.7% 41/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	1.9% 29/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Atrial fibrillation	1.00% 15/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.93% 14/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Pericardial effusion	0.53% 8/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.40% 6/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Atrioventricular block second degree	0.47% 7/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.40% 6/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Atrioventricular block first degree	0.40% 6/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.40% 6/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Bradycardia	0.33% 5/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.47% 7/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Cardiac arrest	0.53% 8/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.20% 3/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Atrioventricular block	0.27% 4/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.33% 5/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Cardiac tamponade	0.40% 6/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.20% 3/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Cardiogenic shock	0.33% 5/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.27% 4/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Cardiac failure	0.33% 5/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.20% 3/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Ventricular tachycardia	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.40% 6/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Bundle branch block right	0.27% 4/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Aortic valve incompetence	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Ventricular fibrillation	0.27% 4/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Bradyarrhythmia	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.20% 3/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Cardiac failure congestive	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Mitral valve incompetence	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Sinus node dysfunction	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Acute myocardial infarction	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Coronary artery occlusion	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Coronary artery stenosis	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Nodal arrhythmia	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Nodal rhythm	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Pericardial haemorrhage	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Prosthetic cardiac valve thrombosis	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Right ventricular failure	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Tachycardia	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Angina pectoris	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Atrial flutter	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Atrial thrombosis	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Bundle branch block	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Cardiac failure acute	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Chronic left ventricular failure	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Coronary artery disease	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Coronary artery insufficiency	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Defect conduction intraventricular	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Myocardial haemorrhage	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Myocardial infarction	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Myocardial rupture	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Pulseless electrical activity	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Right ventricular dysfunction	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Tachyarrhythmia	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Cardiac disorders Torsade de pointes	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Cerebrovascular accident	0.60% 9/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	1.2% 18/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Ischaemic stroke	0.60% 9/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.87% 13/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Transient ischaemic attack	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.27% 4/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Cerebral infarction	0.33% 5/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Embolic stroke	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Cerebral haemorrhage	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Syncope	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Cerebellar infarction	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Cerebellar stroke	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Dementia	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Disturbance in attention	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Encephalopathy	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Haemorrhage intracranial	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Haemorrhagic stroke	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Headache	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Lacunar infarction	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Lumbar radiculopathy	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Presyncope	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Vascular procedure complication	0.60% 9/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	1.0% 15/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.40% 6/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.73% 11/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Postoperative delirium	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Procedural haemorrhage	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.20% 3/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Aortic annulus rupture	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Cardiac valve replacement complication	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Aortic pseudoaneurysm	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Cardiac procedure complication	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Device deployment issue	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Femoral nerve injury	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Iatrogenic injury	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Post procedural fever	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Spinal fracture	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Subdural haematoma	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Injury, poisoning and procedural complications Traumatic haemothorax	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Hypotension	0.40% 6/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.53% 8/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Arterial haemorrhage	0.27% 4/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.20% 3/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Peripheral artery occlusion	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.27% 4/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Peripheral artery stenosis	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Peripheral ischaemia	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.27% 4/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Shock haemorrhagic	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Aortic aneurysm	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Aortic intramural haematoma	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Aortic rupture	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Deep vein thrombosis	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Hypertensive emergency	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Iliac artery occlusion	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Orthostatic hypotension	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Shock	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Aortic arteriosclerosis	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Arteriovenous fistula	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Circulatory collapse	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Haematoma	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Haemodynamic instability	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Haemorrhage	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Hypertension	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Hypertensive urgency	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Hypoperfusion	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Peripheral arterial occlusive disease	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Peripheral artery thrombosis	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Vascular disorders Thrombophlebitis	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
General disorders Catheter site haemorrhage	0.53% 8/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.40% 6/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
General disorders Pyrexia	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.27% 4/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
General disorders Catheter site haematoma	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.27% 4/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
General disorders Device embolisation	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
General disorders Multiple organ dysfunction syndrome	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
General disorders Calcinosis	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
General disorders Extravasation	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Renal and urinary disorders Acute kidney injury	0.80% 12/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.67% 10/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Renal and urinary disorders Haematuria	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Renal and urinary disorders Urinary retention	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Renal and urinary disorders Renal failure	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.60% 9/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.47% 7/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Blood and lymphatic system disorders Anaemia	0.47% 7/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.40% 6/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Blood and lymphatic system disorders Blood loss anaemia	0.27% 4/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.33% 5/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Blood and lymphatic system disorders Thrombocytopenia	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Psychiatric disorders Delirium	0.67% 10/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.67% 10/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Psychiatric disorders Mental status changes	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Product Issues Device dislocation	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.20% 3/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Product Issues Device failure	0.20% 3/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Product Issues Device leakage	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Product Issues Device malfunction	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Product Issues Lead dislodgement	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Infections and infestations Urinary tract infection	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Infections and infestations Corona virus infection	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Infections and infestations Pneumonia	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Infections and infestations Sepsis	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.13% 2/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Infections and infestations Infection	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Infections and infestations Urinary tract infection enterococcal	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.13% 2/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Investigations Cardiovascular function test abnormal	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Investigations Electrocardiogram QRS complex prolonged	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Investigations Troponin increased	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Eye disorders Diplopia	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Eye disorders Retinal artery occlusion	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Hepatobiliary disorders Hepatic function abnormal	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Hepatobiliary disorders Liver disorder	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Endocrine disorders Adrenal insufficiency	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Immune system disorders Hypersensitivity	0.07% 1/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.00% 0/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/1501 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.	0.07% 1/1499 • Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke. All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.

Other adverse events

Adverse event data not reported

Additional Information

Sarah Zanon - Director Clinical Trials, Interventional Cardiology

Boston Scientific

Phone: +41798407006

Email: sarah.zanon@bsci.com

Results disclosure agreements

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