BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 2121362 · Received June 6, 2011

    Report

    Report Number
    2020394-2011-00127
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    February 15, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P06002/S002
    Adverse Event
    Yes
    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 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 A THROMBOTIC OCCLUSION WITHIN THE ENDOVASCULAR STENT GRAFT AT THE VENOUS ANASTOMOSIS. ANGIOPLASTY WAS PERFORMED, 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. ANTF0796

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention ASA