Evidence map›Paper›PMID 39711514›Full record

ArticleJournal of endovascular therapy : an official journal of the International Society of Endovascular Specialists2026

Procedure-Related Mortality in Aspiration Thrombectomy for Pulmonary Embolism: A MAUDE Database Analysis of the Inari FlowTriever and Penumbra Indigo Systems.

Blair E Warren, Kong Teng Tan, Arash Jaberi, Laura Donahoe, Marc de Perrot, Micheal C McInnis, John T Granton, Sebastian Mafeld

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Article in Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Thrombus aspiration andFrontiers in cardiovascular medicine · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Blair E WarrenDepartment of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.ORCID 0000-0003-0832-6358
Kong Teng TanDepartment of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.ORCID 0000-0002-3468-1313
Arash JaberiDepartment of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Laura DonahoeDivision of Thoracic Surgery, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Marc de PerrotDivision of Thoracic Surgery, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Micheal C McInnisDepartment of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.ORCID 0000-0002-5725-3258
John T GrantonDivision of Respirology, Department of Medicine, University Health Network, University of Toronto, Toronto, ON, Canada.
Sebastian MafeldDepartment of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPulmonary embolism (PE) is an important cause of death and disability. Advances in catheter-directed therapies have led to the use of devices, such as the Inari FlowTriever and Penumbra Indigo system for aspiration thrombectomy (AT) for both massive and sub-massive PE. However, limited data exist on causes of procedural mortality.

methodsAnalysis of the Food and Drug Administration's (FDA) Manufacture and User Facility Device Experience (MAUDE) database was performed. Data for the Inari FlowTriever and Penumbra Indigo aspiration thrombectomy systems were evaluated for mortality events and classified by cause of death from January 1, 2015, to December 31, 2023.

resultsThe review identified 26 mortality events related to the Inari FlowTriever and 28 related to the Penumbra Indigo device. Pulmonary vascular perforation (n=26) and right heart injury/tamponade (n=9) were the most common source of mortality. Clot migration (n=4) and acute right heart failure (n=5) were less frequently observed.

conclusionsThis study reveals more mortality events than have been captured in the literature to date. Vascular perforation and cardiac injury are the most common and also potentially preventable sources of mortality. Strategies to mitigate complications related to aspiration thrombectomy are described.Clinical ImpactAnalysis of mortality in aspiration thrombectomy (AT) for acute pulmonary embolism is necessary to better understand the safety profile of this procedure. This analysis of the MAUDE database reports the largest single cohort of 54 deaths. Potentially preventable procedure-related mortality in AT has been documented to be the result of vascular perforation and cardiac perforation with tamponade. Preparation for emergent pericardiocentesis should be considered in mechanical thrombectomy. Clot migration may result from thrombus maceration or migration of clot in transit, thus, careful pre-procedure examination for clot in transit with echocardiography is suggested.

Indexed as

Pulmonary EmbolismThrombectomyAgedDatabases, FactualEquipment DesignFemaleHumansMaleRetrospective StudiesRisk AssessmentRisk FactorsSuctionTime FactorsTreatment Outcomeembolismendovascular treatment/therapythrombectomythrombosisthrombus

Identifiers

PMID39711514
PMCPMC13172114

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.