BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2033267 · Received March 24, 2011

    Report

    Report Number
    MW5019958
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LEFT HEART CATHETERIZATION AND PTCA, WITH ATTEMPTED STENT PLACEMENT. DURING PROCEDURE, THE STENT BALLOON WAS ADVANCED ONTO THE OBTUSE MARGINAL BRANCH OF THE LEFT CORONARY ARTERY. AT THAT TIME, THE STENT DISLODGED FROM THE BALLOON AND HAD TO BE RETRIEVED. THE REMOVAL OF THE FOREIGN BODY -UNDEPLOYED STENT- WAS VIA RE-WIRING BEYOND THE STENT AND DEPLOYMENT OF A FILTER BASKET. THE FILTER BASKET WAS USED TO SNARE THE STENT AND PULL IT BACK INTO THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY STENT SYSTEM, 2.5 X 12 NIQ ABBOTT LABORATORIES, INC. 2.5 MM X 12 MM 0083041

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| S