BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 2152869 · Received June 28, 2011

    Report

    Report Number
    2020394-2011-00148
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002/S002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE STENT GRAFTS REMAIN IMPLANTED AND THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT INVOLVES THE SAME PT AS MANUFACTURER REPORT #2020394-2011-00147.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TWO ENDOVASCULAR STENT GRAFTS MOVED APPROXIMATELY 10-15 CM TO THE BRACHIOCEPHALIC VEIN IMMEDIATELY AFTER DEPLOYMENT AT THE VENOUS ANASTOMOSIS IN AN UPPER ARM LOOP GRAFT. A TRACHEOBRONCHIAL STENT GRAFT WAS THEN ADVANCED TO THE VENOUS ANASTOMOSIS AND IMPLANTED WITHOUT FURTHER INCIDENT. 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. ANVB1707

    Patients

    Seq Age Sex Outcome Treatment
    1