TY  - BOOK
AU  - Ben-Dor, Itsik
AU  - Bernardo, Nelson L
AU  - Case, Brian
AU  - Forrestal, Brian
AU  - Hashim, Hayder
AU  - Kumar, Sant
AU  - Medranda, Giorgio
AU  - Rogers, Toby
AU  - Satler, Lowell F
AU  - Waksman, Ron
AU  - Yerasi, Charan
TI  - Contemporary post-marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database
SN  - 1522-1946
PY  - 2022///
KW  - *Femoral Artery
KW  - *Marketing
KW  - Databases, Factual
KW  - Femoral Artery/dg [Diagnostic Imaging]
KW  - Humans
KW  - Treatment Outcome
KW  - United States Food and Drug Administration
KW  - United States/ep [Epidemiology]
KW  - MedStar Heart & Vascular Institute
KW  - MedStar Washington Hospital Center
KW  - Advanced Cardiac Catheterization Research Fellowship
KW  - Interventional Cardiology Fellowship
KW  - Journal Article
N2  - BACKGROUND: The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access-site closure that was approved by the FDA in 2013. However, post-marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited; CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained 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. Copyright (c) 2021 Wiley Periodicals LLC; METHODS: Post-marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports; OBJECTIVES: To analyze post-marketing 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); RESULTS: 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
UR  - https://dx.doi.org/10.1002/ccd.29942
ER  -