BEUDAMED
    FDA Adverse Event Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 2071316 · Received April 18, 2011

    Report

    Report Number
    2020394-2011-00090
    Date Received
    April 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002/S002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE STENT GRAFT REMAINS IMPLANTED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT FAILED TO COMPLETELY UNFOLD AFTER DEPLOYMENT IN THE VESSEL IN THE UPPER ARM. REPORTEDLY, THE STENT GRAFT WAS OVERSIZED FOR THE VESSEL AND THE DEVICE MIGRATED POST-DEPLOYMENT. THE EXACT MEASUREMENT OF MIGRATION IS UNK, BUT WAS REPORTED TO BE MINOR. THE STENT GRAFT WAS LEFT IN PLACE. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1