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PubMed

Catheter-Directed Interventional Devices for Pulmonary Embolism: A Maude Database Analysis of Adverse Events.

PMID: 42902848 ·

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JournalCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Year
PMID42902848

Abstract

Catheter-directed therapies for acute pulmonary embolism (PE) are being adopted rapidly, yet real-world safety data remain limited. To characterize adverse events, device failure patterns, and mortality signals for three FDA-cleared catheter-directed PE platforms (EKOSONIC, INDIGO, and FlowTriever) using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Medical device reports (MDRs) were downloaded from each device's PE clearance (2008, 2015, and 2018, respectively) thro

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