BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 2121365 · Received June 6, 2011

    Report

    Report Number
    2020394-2011-00128
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    February 4, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE STENT GRAFT REMAINS IMPLANTED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS STENOSIS WITHIN THE ENDOVASCULAR STENT GRAFT. PTA WAS PERFORMED, RESOLVING THE STENOSIS AND RESTORING FLOW THROUGH THE STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANSF2510

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention ERYTHROPOIETIN (EPO)| HEPARIN| ASA