Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
October 20, 2026 · via Europe PMC
Catheter-Directed Interventional Devices for Pulmonary Embolism: A Maude Database Analysis of Adverse Events.
Nandyal S, Gajjar R, Varma R, Vinjamuri S, Athmakuri KS, Vij A
AI summary — for doctors, generated from the abstract only
MAUDE reports show distinct device safety signals for catheter-directed PE therapies, including perforation with large-bore INDIGO and intracranial hemorrhage with EKOSONIC.
What was studied
Analysis of 389 PE-specific FDA MAUDE reports for EKOSONIC, INDIGO and FlowTriever.
Key findings
- 76 deaths (19.5%), 133 injuries and 180 malfunctions.
- Among 47 INDIGO deaths, 59.6% involved large-bore catheters and 76.6% had perforation or bleeding-related codes.
- EKOSONIC reports included intracranial hemorrhage in 8.1%.
Clinical relevance
Alerts operators to device-specific risks in a rapidly growing field.
Who should care
Limitations
Voluntary reporting without procedural denominators, so rates and causality cannot be inferred.
Use careful patient selection and awareness of device-specific risks; report adverse events.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
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.
DOI
10.1002/ccd.70948
PMID
42902848
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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