BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFT

    MDR report key: 2190166 · Received April 24, 2007

    Report

    Report Number
    2017233-2007-00115
    Event Type
    Injury
    Date Received
    April 24, 2007
    Report Date
    April 24, 2007
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN AXILLARY TO DEEP FEMORAL TO ABOVE-KNEE POPLITEAL BYPASS WAS PERFORMED. IT WAS REPORTED BY THE IMPLANTING SURGEON THAT 4 DAYS POSTOPERATIVELY, THE PT PRESENTED WITH A HEMATOMA OVER THE AXILLARY REGION. UPON REINTERVENTION, APPROX 2-3 CM FROM THE GRAFT TO AXILLARY ARTERY ANASTOMOSIS, PULSATILE BLOOD FLOW THROUGH A PINPOINT HOLE IN THE GRAFT WAS OBSERVED. THE HOLE WAS CLOSED WITH 5.0 PROLENE SUTURE. THERE WAS NO GRAFT OCCLUSION OR FAILURE OR LIMB LOSS. PT RECOVERY WAS UNEVENTFUL. THE PINPOINT HOLE IN THE GRAFT APPEARED TO BE AT THE SITE OF RING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFT MIH W.L. GORE & ASSOCIATES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention