{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T06:38:36Z","timestamp":1792564716860,"version":"4.5.0"},"reference-count":14,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:00:00Z","timestamp":1792454400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:00:00Z","timestamp":1792454400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Catheter\u2010directed therapies for acute pulmonary embolism (PE) are being adopted rapidly, yet real\u2010world safety data remain limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To characterize adverse events, device failure patterns, and mortality signals for three FDA\u2010cleared catheter\u2010directed PE platforms (EKOSONIC, INDIGO, and FlowTriever) using the FDA Manufacturer and User Facility Device Experience (MAUDE) database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u2010specific reports. Reports were classified by manufacturer, event type (death, injury, malfunction), device problem, and patient problem, and trends were assessed by calendar year.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 2528 reports, 389 were PE\u2010specific (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\u2010bore catheters, and 36 (76.6%) carried a perforation\u2010, hemoptysis\u2010, tamponade\u2010, or extravasation\u2010related patient problem code. Separator wire break\/fracture was the leading INDIGO device failure. EKOSONIC reports showed thrombolytic\u2010related bleeding, including intracranial or cerebral hemorrhage in 12 reports (8.1%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>MAUDE reports reveal distinct device\u2010specific safety signals: pulmonary artery perforation with large\u2010bore 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\u2010market surveillance.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ccd.70948","type":"journal-article","created":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T05:40:01Z","timestamp":1792561201000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Catheter\u2010Directed Interventional Devices for Pulmonary Embolism: A Maude Database Analysis of Adverse Events"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3153-0787","authenticated-orcid":false,"given":"Shreyas","family":"Nandyal","sequence":"first","affiliation":[{"name":"John H. Stroger Jr. Hospital of Cook County Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2860-2594","authenticated-orcid":false,"given":"Rohan","family":"Gajjar","sequence":"additional","affiliation":[{"name":"John H. Stroger Jr. Hospital of Cook County Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-3048-6375","authenticated-orcid":false,"given":"Revati","family":"Varma","sequence":"additional","affiliation":[{"name":"John H. Stroger Jr. Hospital of Cook County Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saketh","family":"Vinjamuri","sequence":"additional","affiliation":[{"name":"Cleveland Clinic Fairview Hospital  Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krishna Saketh","family":"Athmakuri","sequence":"additional","affiliation":[{"name":"Mayo Clinic  Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1381-5834","authenticated-orcid":false,"given":"Aviral","family":"Vij","sequence":"additional","affiliation":[{"name":"John H. Stroger Jr. Hospital of Cook County Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,20]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"CDC. Venous Thromboembolism (Blood Clots) [Internet]. 2025 [cited 2026 Apr 1]. Data and Statistics on Venous Thromboembolism.https:\/\/www.cdc.gov\/blood-clots\/data-research\/facts-stats\/index.html."},{"key":"e_1_2_9_3_1","unstructured":"Health C for D and R. About Manufacturer and User Facility Device Experience (MAUDE) Database. FDA [Internet]. 2025 Dec 8 [cited 2026 Apr 1].https:\/\/www.fda.gov\/medical-devices\/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities\/about-manufacturer-and-user-facility-device-experience-maude-database."},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2025.07.3795"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.4329\/wjr.v9.i12.426"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2025.12.073"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.74086"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvsvi.2024.100053"},{"key":"e_1_2_9_9_1","unstructured":"C.Toma W.Jaber M.Weinberg et al. Acute Outcomes for the full US cohort of the FLASH Mechanical Thrombectomy Registry in Pulmonary Embolism [Internet]. [cited 2026 Apr 3]. Available from: 1\u20090.4244\/EIJ\u2010D\u201022\u201000732https:\/\/eurointervention.pcronline.com\/article\/acute-outcomes-for-the-full-us-cohort-of-the-flash-mechanical-thrombectomy-registry-in-pulmonary-embolism."},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.124.072364"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.14797\/mdcvj.1344"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.123.013406"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2025.03.018"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.125.077232"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/15266028241307848"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.70948","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.70948","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.70948","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T05:40:02Z","timestamp":1792561202000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.70948"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,20]]},"references-count":14,"alternative-id":["10.1002\/ccd.70948"],"URL":"https:\/\/doi.org\/10.1002\/ccd.70948","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,20]]},"assertion":[{"value":"2026-04-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-20","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"ccd.70948"}}