BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 4200909 · Received September 12, 2014

    Report

    Report Number
    2020394-2014-00415
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT AT THE ANASTOMOSIS IN THE CEPHALIC ARCH, THE STENT GRAFT COULD ONLY BE PARTIALLY DEPLOYED. THE STENT GRAFT WAS EXCHANGED OVER THE GUIDEWIRE WITHOUT INCIDENT FOR A NEW STENT GRAFT THAT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566742 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANXC1872

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown