BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1972220 · Received January 21, 2011

    Report

    Report Number
    2017233-2011-00036
    Event Type
    Injury
    Date Received
    January 21, 2011
    Report Date
    January 20, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, A PATIENT WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT FOR AV ACCESS IN THE ARM. IT WAS REPORTED TO GORE THAT A PORTION OF THE PATIENT'S FINGER WAS AMPUTATED DUE TO THROMBOSIS PRIOR TO 30 DAYS OF IMPLANT. IT WAS STATED THAT THE PATIENT DEVELOPED HEPARIN INDUCED THROMBOCYTOPENIA (HIT) TWO WEEKS AFTER IMPLANTATION. THE PATIENT WAS ADMINISTERED 5000 IU OF HEPARIN INTRAOPERATIVELY. THE PLATELET COUNT DECREASED GREATER THAN 50%. THE GRAFT WAS LEFT IMPLANTED AND TIED OFF AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W.L. GORE & ASSOCIATES,INC WLG450

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability HEPARIN INTRAOPERATIVELY, 5000 IU