BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR

    MDR report key: 2223066 · Received August 19, 2011

    Report

    Report Number
    MW5021845
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AS STENT - 2.5 MM X 23 MM XIENCE - WAS ADVANCED THROUGH GUIDELINER, THE STENT ITSELF WAS STRIPPED BACK ONTO THE BALLOON SHAFT, STENT WAS REMOVED FROM BODY WITHOUT ANY COMPLICATION. SAME SIZE STENT WAS INSERTED VIA THE SAME GUIDELINER WITHOUT ANY COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR XIENCE V NIQ ABBOTT VASCULAR S76201 1020741

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR