BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 2974496 · Received January 28, 2013

    Report

    Report Number
    2020394-2013-00019
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AT THE CEPHALIC VEIN ANASTOMOSIS OF AN A-V FISTULA, THE STENT GRAFT UNEXPECTEDLY MOVED FORWARD DURING DEPLOYMENT. ANOTHER STENT GRAFT WAS IMPLANTED TO COMPLETE TREATMENT OF THE LESION SITE. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38502 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANWF0875

    Patients

    Seq Age Sex Outcome Treatment
    1