Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
Catheter-Directed Interventional Devices for Pulmonary Embolism: A Maude Database Analysis of Adverse Events.
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Nandyal Shreyas, Gajjar Rohan, Varma Revati, Vinjamuri Saketh, Athmakuri Krishna Saketh, Vij Aviral
Аннотация
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.
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.