{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T09:07:15Z","timestamp":1771232835400,"version":"3.50.1"},"reference-count":8,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,9,4]],"date-time":"2021-09-04T00:00:00Z","timestamp":1630713600000},"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":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To analyze post\u2010marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for the VASCADE Vascular Closure System (Cardiva Medical Inc., Santa Clara, CA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access\u2010site closure that was approved by the FDA in 2013. However, post\u2010marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Post\u2010marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 201 reports of major complications involving VASCADE devices, 156 reports involved either injury (145) or death (11) related to the device. Of the 145 injury reports, bleeding was the most common adverse outcome described (85), followed by pseudoaneurysm (29) and pulselessness of an extremity (21). The device malfunction incidents (41 reports) were reported in three main categories, with deployment failure being the most commonly reported complication.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our analysis of the MAUDE database demonstrates that in contemporary post\u2010marketing practice, physicians should be well\u2010trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.29942","type":"journal-article","created":{"date-parts":[[2021,9,4]],"date-time":"2021-09-04T11:45:51Z","timestamp":1630755951000},"page":"822-826","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Contemporary <scp>post\u2010marketing<\/scp> adverse events and modes of failure related to <scp>VASCADE<\/scp> Vascular Closure System: The utility of the <scp>MAUDE<\/scp> database"],"prefix":"10.1002","volume":"99","author":[{"given":"Brian C.","family":"Case","sequence":"first","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sant","family":"Kumar","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giorgio A.","family":"Medranda","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charan","family":"Yerasi","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian J.","family":"Forrestal","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6446-2683","authenticated-orcid":false,"given":"Lowell F.","family":"Satler","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Itsik","family":"Ben\u2010Dor","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hayder","family":"Hashim","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nelson L.","family":"Bernardo","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toby","family":"Rogers","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"},{"name":"Cardiovascular Branch, Division of Intramural Research National Heart, Lung and Blood Institute, National Institutes of Health  Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4063-9226","authenticated-orcid":false,"given":"Ron","family":"Waksman","sequence":"additional","affiliation":[{"name":"Section of Interventional Cardiology MedStar Washington Hospital Center  Washington District of Columbia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,9,4]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0034-1393972"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2009.12.027"},{"key":"e_1_2_9_4_1","article-title":"Treatment of common femoral artery Pseudoaneurysm: a novel approach utilizing a VASCADE percutaneous closure device","volume":"2019","author":"Dalvin M","year":"2019","journal-title":"Case Rep Surg"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-010-9981-0"},{"key":"e_1_2_9_6_1","first-page":"129","article-title":"A prospective, randomized, pivotal trial of a novel extravascular collagen\u2010based closure device compared to manual compression in diagnostic and interventional patients","volume":"27","author":"Hermiller JB","year":"2015","journal-title":"J Invasive Cardiol"},{"key":"e_1_2_9_7_1","unstructured":"US Food and Drug Administration.MAUDE \u2010 Manufacturer and User Facility Device Experience. Accessed January 16 2021."},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.carrev.2020.08.038"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2019.08.013"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.29942","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.29942","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.29942","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T22:21:48Z","timestamp":1692570108000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.29942"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,4]]},"references-count":8,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,2]]}},"alternative-id":["10.1002\/ccd.29942"],"URL":"https:\/\/doi.org\/10.1002\/ccd.29942","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,4]]},"assertion":[{"value":"2021-03-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-08-23","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-09-04","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}