BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 1060415 · Received June 12, 2008

    Report

    Report Number
    2017233-2008-00329
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 12, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PHYSICIAN INTENDED TO SURGICALLY PLACE A CONDUIT INTO THE PATIENT'S RIGHT COMMON ILIAC ARTERY TO OBTAIN ACCESS FOR ENDOVASCULAR REPAIR. HOWEVER, THE CONDUIT WAS SURGICALLY PLACED INTO THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. WHEN A 24 FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS ADVANCED THROUGH THE CONDUIT, THE CONDUIT AND THE PT'S RIGHT EXTERNAL ILIAC ARTERY TORE. THE PT HAD SIGNIFICANT BLOOD LOSS AND A BLOOD TRANSFUSION WAS ADMINISTERED. IT WAS REPORTED THAT THE PT'S RIGHT EXTERNAL ILIAC ARTERY WAS REPAIRED, A SECOND CONDUIT WAS SURGICALLY PLACED INTO THE PT'S RIGHT COMMON ILIAC ARTERY, AND THAT THE PROCEDURE CONTINUED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE NONE DYB W. L. GORE & ASSOCIATES, INC. WLG340 05708523

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention