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

Background Catheter‐directed therapies for acute pulmonary embolism (PE) are being adopted rapidly, yet real‐world safety data remain limited. Aims 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. Methods Medical device reports (MDRs) were downloaded from each device's PE clearance (2008, 2015, and 2018, respectively) through March 2026 and filtered by text to retain PE‐specific reports. Reports were classified by manufacturer, event type (death, injury, malfunction), device problem, and patient problem, and trends were assessed by calendar year. Results Of 2528 reports, 389 were PE‐specific (INDIGO 228 [58.6%], EKOSONIC 149 [38.3%], FlowTriever 12 [3.1%]), spanning 2009 to January 2026. There were 76 deaths (19.5%), 133 injuries (34.2%), and 180 malfunctions (46.3%). Annual death reports rose from 2023 (15 in 2023, 13 in 2024, 8 in 2025, and 3 in January 2026). Among 47 INDIGO deaths, 28 (59.6%) involved Lightning/Flash large‐bore catheters, and 36 (76.6%) carried a perforation‐, hemoptysis‐, tamponade‐, or extravasation‐related patient problem code. Separator wire break/fracture was the leading INDIGO device failure. EKOSONIC reports showed thrombolytic‐related bleeding, including intracranial or cerebral hemorrhage in 12 reports (8.1%). Conclusions MAUDE reports reveal distinct device‐specific safety signals: pulmonary artery perforation with large‐bore INDIGO aspiration catheters, and intracranial hemorrhage with EKOSONIC. Death reports increased from 2023 as mechanical thrombectomy use expanded. Absent procedural denominators, rates and causality cannot be inferred; findings support operator awareness, careful patient selection, and continued post‐market surveillance.