BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 1951902 · Received December 28, 2010

    Report

    Report Number
    2020394-2010-00372
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 30, 2010
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE STENT GRAFT REMAINS IMPLANTED. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED WITH STENOSES AND THROMBOSIS WITHIN THE AV GRAFT CIRCUIT APPROX TEN MONTHS POST STENT GRAFT IMPLANT. THROMBECTOMY WAS PERFORMED ON THE ACCESS CIRCUIT. PTA OF A STENOSIS INVOLVING THE JUNCTURE OF THE INTERPOSITION EPTFE GRAFT AND DISTAL PORTION OF THE STENT GRAFT WAS PERFORMED. PTA WAS ALSO PERFORMED ON A POSSIBLE STENOSIS WITHIN THE BODY OF THE STENT GRAFT, WITH EXCELLENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANTD0187

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention HEPARIN| ERYTHROPOIETIN| ASA