BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 2983274 · Received February 1, 2013

    Report

    Report Number
    2020394-2013-00025
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 11, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT, THE STENT GRAFT MOVED CENTRALLY TO THE SUBCLAVIAN VEIN. A PTA BALLOON WAS USED TO BRING THE STENT GRAFT BACK TO THE INTENDED PLACEMENT SITE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45269 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANWE4047

    Patients

    Seq Age Sex Outcome Treatment
    1