TCT-454 Complications and Failure Modes of Inari FlowTriever Aspiration System in Pulmonary Embolism: Insights From the MAUDE Database

Document Type

Conference Proceeding

Publication Date

11-1-2021

Publication Title

J Am Coll Cardiol

Abstract

Background: The Inari FlowTriever aspiration system (Inari Medical) gained US Food and Drug Administration approval in May 2018 for use in pulmonary embolism. Data on its failure mechanisms are limited.

Methods: We investigated the Manufacturer and User Facility Device Experience database for reports on Inari FlowTriever aspiration system failure from June 2018 to May 2021. The outcomes of this study were the device failure modes and their clinical consequences.

Results: A total of 27 reports were found during the study period. After excluding duplicate reports (n = 6), incomplete ones (n = 1), and those of deep venous thrombosis without pulmonary embolism (n = 4), our final cohort included 16 reports. Injury to the pulmonary vessels occurred in 6 reports (37.5%), with pulmonary perforation being the most common type of injury, occurring in 3 reports (18.8%), followed by pulmonary pseudoaneurysm in 2 reports (12.5%) and pulmonary dissection in 1 report (6.3%). Hemoptysis occurred in 4 reports (25%) and pericardial effusion in 3 reports (18.8%), and blood transfusion was needed in 5 reports (31.3%). Cardiopulmonary arrest occurred in 11 (68.8%) and death in 10 (62.5%) reports.

Conclusion: We found that reports of Inari FlowTriever Aspiration System failure were rare (16 over 3 years). However, failure reports were serious and included pulmonary artery injury and hemoptysis. Careful catheter manipulation may help avoid such complications.

Volume

78

Issue

19

First Page

B187

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