Trial Outcomes & Findings for FlowTriever for Acute Massive Pulmonary Embolism (FLAME) (NCT NCT04795167)

NCT ID: NCT04795167

Last Updated: 2025-04-30

Results Overview

The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%. Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

• Recruitment status: COMPLETED
• Target enrollment: 115 participants
• Primary outcome timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
• Results posted on: 2025-04-30

Participant Flow

All patients presenting to the hospital/emergency department with PE or who incidentally develop PE while in the hospital were assessed for high-risk PE, and for eligibility for enrollment in the FLAME study.

Subjects who met eligibility criteria for the study and had a primary thrombus removal strategy initiated were enrolled into either the FlowTriever, Context or Prior Therapy Arm, based on the thrombus removal strategy initiated. These three arms were non-randomized parallel registries.

Participant milestones

Measure	FlowTriever Arm Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\] systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\]	Prior Therapy Arm Subjects presenting with low or intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission
Overall Study STARTED	53	61	1
Overall Study COMPLETED	48	43	0
Overall Study NOT COMPLETED	5	18	1

Reasons for withdrawal

Measure	FlowTriever Arm Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\] systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\]	Prior Therapy Arm Subjects presenting with low or intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission
Overall Study Death	1	18	1
Overall Study Remained in-hospital for >/= 45 Days	4	0	0

Baseline Characteristics

FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

Baseline characteristics by cohort

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE.	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm n=1 Participants Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission	Total n=115 Participants Total of all reporting groups
Age, Continuous	64.8 years n=5 Participants	61.6 years n=7 Participants	58.0 years n=5 Participants	63.0 years n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	35 Participants n=7 Participants	1 Participants n=5 Participants	62 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	0 Participants n=5 Participants	53 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	43 Participants n=7 Participants	0 Participants n=5 Participants	82 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	16 Participants n=7 Participants	1 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	40 Participants n=7 Participants	0 Participants n=5 Participants	56 Participants n=4 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	51 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment United States	53 participants n=5 Participants	61 participants n=7 Participants	1 participants n=5 Participants	115 participants n=4 Participants

PRIMARY outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever Arm and Context Arm. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%.

Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding	9 Participants	39 Participants	—

SECONDARY outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

Incidence of mortality

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
All-Cause Mortality	1 Participants	18 Participants	—

SECONDARY outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

Incidence of bailout to an alternative thrombus removal strategy

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Bailout to an Alternative Thrombus Removal Strategy	2 Participants	16 Participants	—

SECONDARY outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

Incidence of clinical deterioration

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Clinical Deterioration	8 Participants	13 Participants	—

SECONDARY outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

Incidence of major bleeding

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Major Bleeding	6 Participants	15 Participants	—

SECONDARY outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

Incidence of ischemic or hemorrhagic stroke

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Frequency of Stroke	1 Participants	4 Participants	—

SECONDARY outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

Incidence of device-related complications

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Device-related Complications	12 Participants	10 Participants	—

SECONDARY outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

Incidence of access site injury requiring intervention, including both venous and arterial

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Access Site Injury Requiring Intervention, Both Venous and Arterial	4 Participants	5 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in FlowTriever, Context and Prior Therapy Arms who survived to discharge or 45 days, whichever comes first.

Length of post-treatment hospital stay, measured in number of overnights

Outcome measures

Measure	FlowTriever Arm n=52 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=43 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Length of Hospital Stay	7 Days Interval 3.0 to 12.5	8 Days Interval 6.0 to 15.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From treatment start or ICU admission, whichever is later, to ICU discharge

Population: All patients in the FlowTriever, Context and Prior Therapy Arms who survived to discharge or study exit

Length of post-treatment ICU stay, measure in number of overnights

Outcome measures

Measure	FlowTriever Arm n=52 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=43 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Length of ICU Stay	2 Days Interval 1.0 to 4.0	3 Days Interval 1.0 to 7.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in FlowTriever, Context and Prior Therapy Arms

Frequency of ECMO use, including either pre or post treatment initiation

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm n=1 Participants Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Use of ECMO	3 Participants	7 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Population: All patients in the FlowTriever, Context and Prior Therapy Arms

Discharge location after hospital stay

Outcome measures

Measure	FlowTriever Arm n=53 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm n=1 Participants Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Discharge Location Home with healthcare	6 Participants	3 Participants	0 Participants
Discharge Location Home	26 Participants	23 Participants	0 Participants
Discharge Location Care facility/skilled nursing home	13 Participants	11 Participants	0 Participants
Discharge Location Stayed in hospital for >/= 45 days	4 Participants	0 Participants	0 Participants
Discharge Location Expired prior to discharge	1 Participants	18 Participants	1 Participants
Discharge Location Other	3 Participants	6 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of initiation of primary treatment to extubation

Population: All patients in the FlowTriever Arm, Context Arm and Prior Therapy arm who survived to discharge or study exit, underwent a single intubation procedure prior to initiation of primary treatment, and were extubated prior to and through discharge or study exit

Time to extubation reported as number of days

Outcome measures

Measure	FlowTriever Arm n=4 Participants Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=6 Participants Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Time to Extubation	1.640 Days Interval 1.2 to 4.305	1.795 Days Interval 1.53 to 3.06	—

Adverse Events

FlowTriever Arm

Serious events: 16 serious events

Other events: 10 other events

Deaths: 1 deaths

Context Arm

Serious events: 37 serious events

Other events: 19 other events

Deaths: 18 deaths

Prior Therapy Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	FlowTriever Arm n=53 participants at risk Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 participants at risk Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm n=1 participants at risk Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Renal and urinary disorders Acute kidney injury	5.7% 3/53 • Number of events 3 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	6.6% 4/61 • Number of events 4 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	100.0% 1/1 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	3.3% 2/61 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Blood and lymphatic system disorders Anaemia	7.5% 4/53 • Number of events 4 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	6.6% 4/61 • Number of events 4 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Anaemia postoperative	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Arterial haemorrhage	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Arterial occlusive disease	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Atrial Fibrillation	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Surgical and medical procedures Atrial repair	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Brain Hypoxia	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	4.9% 3/61 • Number of events 3 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Breast haematoma	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Cardiac arrest	3.8% 2/53 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	6.6% 4/61 • Number of events 4 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Cardiogenic shock	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Nervous system disorders Cerebellar infarction	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Nervous system disorders Cerebrovascular accident	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	3.3% 2/61 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Chest wall haematoma	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Deep vein thrombosis	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	3.3% 2/61 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
General disorders General physical health deterioration	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Haematoma	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	4.9% 3/61 • Number of events 3 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Renal and urinary disorders Haematuria	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Haemodynamic instability	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Investigations Haemoglobin decreased	5.7% 3/53 • Number of events 3 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	4.9% 3/61 • Number of events 3 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	3.3% 2/61 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Nervous system disorders Haemorrhage intracranial	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	3.8% 2/53 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Hypotension	3.8% 2/53 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	6.6% 4/61 • Number of events 4 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	100.0% 1/1 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Obstructive shock	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Orbital haematoma	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Pericardial effusion	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Peripheral ischaemia	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 2/53 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Pulmonary embolism	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	6.6% 4/61 • Number of events 4 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Pulmonary haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Pulseless electrical activity	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	13.1% 8/61 • Number of events 8 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.8% 2/53 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Right ventricular failure	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Infections and infestations Sepsis	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Infections and infestations Septic shock	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	100.0% 1/1 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Shock haemorrhagic	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	3.3% 2/61 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Gastrointestinal disorders Small intestinal obstruction	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
General disorders Swelling	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Thrombosis	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Tooth socket haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Investigations Transaminases increased	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Vascular access site haematoma	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Vascular access site haemorrhage	3.8% 2/53 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	6.6% 4/61 • Number of events 4 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Worsening Respiratory Failure	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	100.0% 1/1 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Investigations Worsening Shock Liver	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	100.0% 1/1 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	100.0% 1/1 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.

Other adverse events

Measure	FlowTriever Arm n=53 participants at risk Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE	Context Arm n=61 participants at risk Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\])	Prior Therapy Arm n=1 participants at risk Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Renal and urinary disorders Haematuria	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Blood and lymphatic system disorders Anaemia	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Infections and infestations Bacteraemia	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Blood and lymphatic system disorders Blood loss anaemia	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders COVID-19	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Cardiac arrest	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Deep vein thrombosis	3.8% 2/53 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	6.6% 4/61 • Number of events 4 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Haemodynamic instability	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Hypotension	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
General disorders Injection site haematoma	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Gastrointestinal disorders Melaena	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Pelvic haematoma	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Pulmonary embolism	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Cardiac disorders Pulseless electrical activity	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	3.3% 2/61 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Nervous system disorders Seizure	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Infections and infestations Septic shock	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Skin haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Tongue biting	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Vascular disorders Tongue haemorrhage	0.00% 0/53 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Investigations Transaminases increased	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Vascular access site haematoma	1.9% 1/53 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/61 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
Injury, poisoning and procedural complications Vascular access site haemorrhage	3.8% 2/53 • Number of events 2 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	1.6% 1/61 • Number of events 1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.	0.00% 0/1 • Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first) The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.

Additional Information

Ashleigh Willson

Inari Medical

Phone: 925-330-3446

Email: ashleigh.willson@inarimedical.com

Results disclosure agreements

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

Restriction type: GT60