BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 2111772 · Received May 25, 2011

    Report

    Report Number
    2017233-2011-00250
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 24, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE MFG AND STERILIZATION RECORD HISTORY. REVIEW OF DEVICE MFG AND STERILIZATION RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A GORE HYBRID VASCULAR GRAFT WAS IMPLANTED IN AN ARTERIAL BYPASS APPLICATION. THE PROCEDURE WAS PERFORMED IN THE PT'S RIGHT UPPER ARM. ON (B)(6) 2011, A THROMBECTOMY AND AN ANGIOPLASTY WERE PERFORMED. ON (B)(6) 2011, A GRAFT HEMATOMA WAS NOTED, AND A CATHETER WAS PLACED. ON (B)(6) 2011, THE INFECTED GRAFT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HYBRID VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES WLG417 8426148

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention