BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 2030370 · Received March 22, 2011

    Report

    Report Number
    2020394-2011-00056
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002/S002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE CURRENTLY BEING REVIEWED. THE SAMPLE HAS NOT YET BEEN RETURNED TO THE MFR. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT FAILED TO DEPLOY AND UPON RETRACTING THE DELIVERY SYSTEM, THE STENT GRAFT PARTIALLY DEPLOYED IN THE VESSEL. THE STENT GRAFT WAS LEFT IN PLACE AND ANOTHER WAS IMPLANTED AT THE INTENDED TREATMENT SITE W/O INCIDENT. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANUI1989

    Patients

    Seq Age Sex Outcome Treatment
    1