{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:02:54Z","timestamp":1789689774189,"version":"4.0.1"},"reference-count":5,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T00:00:00Z","timestamp":1694044800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cardiovasc electrophysiol"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second\u2010generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real\u2010world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 59 adverse events were reported, of which 58 were sheath\u2010related events, and one was a wire\u2010related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient\u2010related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>LAAO\u2010related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jce.16053","type":"journal-article","created":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T06:03:42Z","timestamp":1694153022000},"page":"2382-2385","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Adverse events associated with amplatzer left atrial appendage occlusion delivery system: A Food and Drug Administration MAUDE database study"],"prefix":"10.1111","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0959-5576","authenticated-orcid":false,"given":"Jakrin","family":"Kewcharoen","sequence":"first","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1345-0719","authenticated-orcid":false,"given":"Kuldeep","family":"Shah","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service MercyOne Siouxland Heart and Vascular Center Sioux City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7734-8660","authenticated-orcid":false,"given":"Rahul","family":"Bhardwaj","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tahmeed","family":"Contractor","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohit K.","family":"Turagam","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service, Helmsley Electrophysiology Center Icahn School of Medicine at Mount Sinai New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravi","family":"Mandapati","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1492-2693","authenticated-orcid":false,"given":"Dhanunjaya","family":"Lakkireddy","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Kansas City Heart Rhythm Institute and Research Foundation Kansas City Kansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6857-7418","authenticated-orcid":false,"given":"Jalaj","family":"Garg","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,9,7]]},"reference":[{"key":"e_1_2_4_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.121.057063"},{"issue":"5","key":"e_1_2_4_3_1","article-title":"Periprocedural pericardial effusion complicating transcatheter left atrial appendage occlusion: a report from the NCDR LAAO Registry","volume":"15","author":"Price MJ","year":"2022","journal-title":"Circul Cardiovasc Intervent"},{"key":"e_1_2_4_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.12.040"},{"key":"e_1_2_4_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2022.06.003"},{"key":"e_1_2_4_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2021.12.034"}],"container-title":["Journal of Cardiovascular Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jce.16053","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,18]],"date-time":"2023-11-18T03:45:14Z","timestamp":1700279114000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jce.16053"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,7]]},"references-count":5,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1111\/jce.16053"],"URL":"https:\/\/doi.org\/10.1111\/jce.16053","archive":["Portico"],"relation":{},"ISSN":["1045-3873","1540-8167"],"issn-type":[{"value":"1045-3873","type":"print"},{"value":"1540-8167","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,7]]},"assertion":[{"value":"2023-05-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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