BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2071313 · Received April 22, 2011

    Report

    Report Number
    2071313
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STENT BALLOON FAILED TO INFLATE. STENT REMOVED AND NEW ONE USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR * 0120341

    Patients

    Seq Age Sex Outcome Treatment
    1 * CARDIAC DRUGS