BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2071937 · Received April 25, 2011

    Report

    Report Number
    2017233-2011-00212
    Event Type
    Death
    Date Received
    April 25, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 21, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK HAS NOT BEEN COMPLETED. GORE EXCLUDER AAA DEVICES ASSOCIATED WITH THIS EVENT: RMT311417/8777983, PXC141400/8398632, PXC141000/8602095 (REFER TO MANUFACTURER REPORT# 2017233-2011-00211).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM AND TWO GORE EXCLUDER AAA CONTRALATERAL LEG ENDOPROSTHESES. THE DEVICES WERE PLACED WITHOUT INCIDENT. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF AN ENDOLEAK. DIFFICULTIES WERE ENCOUNTERED AT THE END OF THE PROCEDURE WHEN THE GROINS WERE BEING CLOSED USING PERCUTANEOUS CLOSURE DEVICES. POST-OPERATIVELY, WITHIN AN HOUR, THE PT LOST PULSE IN ONE LEG DUE TO COMPLICATIONS ASSOCIATED WITH A FAILED PERCUTANEOUS CLOSURE. THE PT WAS TRANSFERRED TO THE OPERATING ROOM TO STOP THE BLEEDING AND SURGICALLY CLOSE THE GROIN. THE PT WAS STABILIZED. ON (B)(6) 2011, THE PT DIED. THE CAUSE OF DEATH WAS HEPATIC FAILURE, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), KIDNEY FAILURE, AND CARDIOPULMONARY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DRYSEAL SHEATH DYB / INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES WLG401 7703563

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death SIMVASTATIN| ATENOLOL| LISINOPRIL| TRICOR| NORVASC