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

doi:10.1177/15266028241307848

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

J Endovasc Ther. 2024 Dec 23:15266028241307848. doi: 10.1177/15266028241307848. Online ahead of print.

Authors

Blair E Warren^{1

2}, Kong Teng Tan^{1

2}, Arash Jaberi^{1

2}, Laura Donahoe³, Marc de Perrot³, Micheal C McInnis^{1

4}, John T Granton⁵, Sebastian Mafeld^{1

2

6}

Affiliations

¹ Department of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
² Division of Vascular and Interventional Radiology, Joint Department of Medical Imaging, University Health Network, University of Toronto, Toronto, ON, Canada.
³ Division of Thoracic Surgery, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
⁴ Division of Cardiothoracic and Vascular Imaging, Joint Department of Medical Imaging, University Health Network, University of Toronto, Toronto, ON, Canada.
⁵ Division of Respirology, Department of Medicine, University Health Network, University of Toronto, Toronto, ON, Canada.
⁶ Peter Munk Cardiac Centre, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.

PMID: 39711514
DOI: 10.1177/15266028241307848

Abstract

Background: Pulmonary 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.

Methods: Analysis 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.

Results: The 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.

Conclusions: This 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 impact: Analysis 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.

Keywords: embolism; endovascular treatment/therapy; thrombectomy; thrombosis; thrombus.