Trends, Modes of Failure, and Complications of Mechanical Thrombectomy Devices Using the Manufacturer and User Facility Device Experience (MAUDE) Database

Monday, March 31, 2025

4:12 PM – 4:21 PM CT

Location: Music City Center, 202 BC

Presenting Author(s)

Shriya L. Veluri (she/her/hers)

Medical Student
UT Health San Antonio, United States

Author/Co-author(s)

Carson Middlebrook

Medical Student
Michigan State University College of Osteopathic Medicine, United States
ZH

Zaher Hakim, MD

Interventional Cardiologist
Detroit Medical Center, United States

Purpose: Pulmonary embolism (PE) is characterized by the sudden blockage of a pulmonary artery, typically due to a thrombus originating from deep veins of the lower extremities. Standard treatment for PE includes anticoagulation therapy; however, in cases of massive or high-risk PE, more aggressive interventions may be necessary. Mechanical thrombectomy (MT) has emerged as a critical intervention in such scenarios. In particular, interventional radiologists utilize mechanical thrombectomy devices (MTDs) to remove, fragment, or disperse thrombi through various mechanisms.

The aim of this study is to investigate MTD-related adverse events (AEs) to better understand their safety profile.

Materials and Methods:
Using the Manufacturer and User Facility Device Experience (MAUDE) database, a retrospective analysis of AE reports for MTDs between May 1, 2005 and May 1, 2024 was conducted. Only MTDs indicated in the removal of acute or chronic pulmonary vasculature thrombi (Inari FlowTriever, Penumbra Indigo Aspiration, and AngioDynamics AngioVac Systems), were included. Data were extracted on device malfunctions, patient injuries, and procedural complications, and reports were categorized by event type and manufacturer. Descriptive statistics were employed to summarize the frequency and nature of these AEs, and trends over time were analyzed.

Results: 147 AE reports were identified, with the majority involving Penumbra (81.6%), Inari (10.2%), and AngioDynamics (8.2%) MTDs. AEs include death (25.9%), patient injury (29.3%), and device malfunction (44.9%). The most common types of patient injury include hemoptysis (37.2%), cardiac tamponade (9.3%), and hypotension (9.3%), although the diagnosis was unspecified in 32.6% of injuries. The most common device malfunctions were unidentified device or use problems (28.8%), material deformation (19.7%), and breaks (16.7%). Although no clear trends have been elucidated from the data, there has been an overall decrease in reported AEs since 2021.

Conclusion: The number of reported AEs associated with MTDs underscores the need for continuous monitoring and improvement of device design and procedural techniques. Enhanced training for clinicians and rigorous post-market surveillance are recommended to mitigate these risks and improve patient outcomes.