Trial Outcomes & Findings for FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (NCT NCT03761173)

Last Updated: 2025-10-01

Results Overview

MAEs are defined as a composite, when one or more of the following events occur: * Device-related mortality through 48 hours after the index procedure, or * Major bleeding through 48 hours after the index procedure, or * Intra-procedural device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor.

Recruitment status

COMPLETED

Target enrollment

1200 participants

Primary outcome timeframe

48-hours after index procedure

Results posted on

2025-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	FlowTriever Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy
Overall Study STARTED	1000
Overall Study COMPLETED	758
Overall Study NOT COMPLETED	242

Reasons for withdrawal

Reasons for withdrawal
Measure	FlowTriever Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy
Overall Study Lost to Follow-up	93
Overall Study Withdrawal by Subject	74
Overall Study Death	45
Overall Study Withdrawal for Other Reasons	29
Overall Study Protocol Violation	1

Baseline Characteristics

Data was missing for one subject.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FlowTriever n=999 Participants Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy
Age, Categorical <=18 years	0 Participants n=998 Participants • Data was missing for one subject.
Age, Categorical Between 18 and 65 years	547 Participants n=998 Participants • Data was missing for one subject.
Age, Categorical >=65 years	451 Participants n=998 Participants • Data was missing for one subject.
Age, Continuous	61.6 years STANDARD_DEVIATION 14.3 • n=998 Participants • Data was missing for one subject.
Sex: Female, Male Female	453 Participants n=999 Participants
Sex: Female, Male Male	546 Participants n=999 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=999 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	698 Participants n=999 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	281 Participants n=999 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=999 Participants
Race (NIH/OMB) Asian	5 Participants n=999 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=999 Participants
Race (NIH/OMB) Black or African American	192 Participants n=999 Participants
Race (NIH/OMB) White	572 Participants n=999 Participants
Race (NIH/OMB) More than one race	1 Participants n=999 Participants
Race (NIH/OMB) Unknown or Not Reported	227 Participants n=999 Participants
BMI (kg/m^2)	33.8 kg/m^2 STANDARD_DEVIATION 8.1 • n=995 Participants • Data was missing for four subjects.
Prior History of PE Yes	101 Participants n=999 Participants
Prior History of PE No	898 Participants n=999 Participants
PE Classification High Risk	143 Participants n=997 Participants • Data was missing for two subjects.
PE Classification Intermediate-High Risk	718 Participants n=997 Participants • Data was missing for two subjects.
PE Classification Intermediate-Low Risk	65 Participants n=997 Participants • Data was missing for two subjects.
PE Classification Intermediate Risk, Not Further Classified	71 Participants n=997 Participants • Data was missing for two subjects.
Prior History of DVT Yes	187 Participants n=998 Participants • Data was missing for one subject.
Prior History of DVT No	811 Participants n=998 Participants • Data was missing for one subject.
Concomitant DVT Yes	621 Participants n=989 Participants • Data was missing for 10 subjects.
Concomitant DVT No	368 Participants n=989 Participants • Data was missing for 10 subjects.
DVT Location Proximal Only	209 Participants n=613 Participants • Data was collected for subjects with Concomitant DVT. Data was missing for eight subjects.
DVT Location Distal Only	308 Participants n=613 Participants • Data was collected for subjects with Concomitant DVT. Data was missing for eight subjects.
DVT Location Both	96 Participants n=613 Participants • Data was collected for subjects with Concomitant DVT. Data was missing for eight subjects.
History of Cancer Yes	210 Participants n=999 Participants
History of Cancer No	789 Participants n=999 Participants
Active Cancer Yes	94 Participants n=210 Participants • Active cancer was collected for subjects with cancer history.
Active Cancer No	116 Participants n=210 Participants • Active cancer was collected for subjects with cancer history.
Lytic Contraindication Yes	303 Participants n=998 Participants • Data was missing for one subject.
Lytic Contraindication No	695 Participants n=998 Participants • Data was missing for one subject.

PRIMARY outcome

Timeframe: 48-hours after index procedure

Population: Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 11 subjects, yielding 988 analyzed subjects.

Outcome measures

Outcome measures
Measure	FlowTriever n=988 Participants Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy
Subjects With Major Adverse Events Yes	24 Participants
Subjects With Major Adverse Events No	964 Participants

SECONDARY outcome

Timeframe: 48-hours after the index procedure

Population: Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 13 subjects, yielding 986 analyzed subjects.

Rate of subjects with device related mortality through 48 hours post index procedure

Outcome measures

Outcome measures
Measure	FlowTriever n=986 Participants Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy
Device-Related Mortality Yes	0 Participants
Device-Related Mortality No	986 Participants

SECONDARY outcome

Timeframe: 48 hours after index procedure

Population: Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 12 subjects, yielding 987 analyzed subjects.

Rate of subjects with major bleeding through 48 hours after the index procedure (fatal bleeding; symptomatic bleeding in a critical area or organ; bleeding causing a fall in hemoglobin of ≥5 g/dL or leading to transfusion of 2 or more units of blood products)

Outcome measures

Outcome measures
Measure	FlowTriever n=987 Participants Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy
Major Bleeding Yes	17 Participants
Major Bleeding No	970 Participants

SECONDARY outcome

Timeframe: Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.

Intraprocedural Device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury.

Outcome measures

Outcome measures
Measure	FlowTriever n=987 Participants Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy
Intraprocedural Device-related or Procedure-related Adverse Events Yes	8 Participants
Intraprocedural Device-related or Procedure-related Adverse Events No	979 Participants

Adverse Events

FlowTriever

Serious events: 125 serious events

Other events: 0 other events

Deaths: 45 deaths

Serious adverse events

Serious adverse events
Measure	FlowTriever n=999 participants at risk Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy
Vascular disorders Pulmonary Embolism	1.2% 12/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Deep Vein Thrombosis	0.60% 6/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Haemodynamic Instability	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Haemorrhage	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Ischaemic Stroke	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Hypotension	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Retroperitoneal Haematoma	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Shock Haemorrhagic	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Atrial Thombosis	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Coronary Artery Stenosis	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Hypovolaemic Shock	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Intra-Abdominal Haematoma	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Leriche Syndrome	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Peripheral Ischaemia	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Post Procedural Pulmonary Embolism	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Retroperitoneal Haemorrhage	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Shock	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Subarachnoid Haemorrhage	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Syncope	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Vascular disorders Vasoplegia Syndrome	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Cardiac Arrest	0.50% 5/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Bradycardia	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Cardio-Respiratory Arrest	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Cardiac Failure	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Acute Pulmonary Oedema	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Aortic Valve Stenosis	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Atrial Fibrillation	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Bundle Branch Block, Left	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Cardiac Failure, Congestive	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Chest Discomfort	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Pericardial Effusion	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Cardiac disorders Tachycardia	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Vascular Access Site Haematoma	0.50% 5/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Vascular Access Site Haemorrhage	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Subdural Haematoma	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Cardiac Procedure Complication	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Cardiac Valve Rupture	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Contrast Media Toxicity	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Overdose	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Injury, poisoning and procedural complications Vascular Access Site Complication	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Metastatic	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer Stage IV	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative Disorder	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mallignant Neoplasm Progression	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Squamous Cell Carcinoma	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma, Metastatic	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer, Metastatic	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Neoplasm	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Influenza	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Lower Respiratory Tract Infection	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Pneumonia	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Pneumonia Pneumococcal	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Respiratory, thoracic and mediastinal disorders Tracheal Injury	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Blood and lymphatic system disorders Anaemia	0.80% 8/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Blood and lymphatic system disorders Blood Loss Anaemia	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Blood and lymphatic system disorders Heparin-induced Thrombocytopenia	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Blood and lymphatic system disorders Plasma Cell Myeloma	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
General disorders Death	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
General disorders Multiple Organ Dysfunction Syndrome	0.30% 3/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Infections and infestations Septic Shock	0.20% 2/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Infections and infestations Groin Abscess	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Infections and infestations Sepsis	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Gastrointestinal disorders Colon Cancer	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Gastrointestinal disorders Intestinal Perforation	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Gastrointestinal disorders Large Intestine Perforation	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Nervous system disorders Cerebrovascular Accident	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Nervous system disorders Generalised Tonic-Clonic Seizure	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Nervous system disorders Metabolic Encephalopathy	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Investigations Haemoglobin Decreased	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Psychiatric disorders Mental Status Change	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Reproductive system and breast disorders Vaginal Haemorrhage	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Surgical and medical procedures Arterial Repair	0.10% 1/999 • Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early. Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor. Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).

Other adverse events

Adverse event data not reported

Additional Information

Ashleigh Willson

Inari Medical, Now Part of Stryker

Phone: 925-330-3446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place