BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 2211283 · Received August 3, 2011

    Report

    Report Number
    2020394-2011-00179
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    November 3, 2010
    Report Date
    July 8, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT, AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. NO ADDITIONAL COMPLAINT HAS BEEN PREVIOUSLY REPORTED FOR THIS LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE STENT GRAFT REMAINS IMPLANTED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ELEVEN MONTHS POST STENT GRAFT IMPLANT IN THE LEFT UPPER ARM, THE PATIENT PRESENTED WITH STENOSES IN THE AV GRAFT AND THE STENT GRAFT, WHICH WERE TREATED WITH BALLOON ANGIOPLASTY. APPROXIMATELY SIX MONTHS LATER, THE AV GRAFT AND THE STENT GRAFT RE-STENOSED AND BALLOON ANGIOPLASTY WAS AGAIN SUCCESSFULLY PERFORMED. THE PATIENT RECOVERED WITH NO CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANSL0754

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention