BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1881122 · Received October 20, 2010

    Report

    Report Number
    2017233-2010-00464
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    December 26, 2009
    Report Date
    October 19, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. A REVIEW OF THE STERILIZATION PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE STERILIZATION PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICE IMPLANTED: PXC121000/06516234.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS EXCLUDED AND THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2009, THE PT PRESENTED TO THE EMERGENCY ROOM WITH PROSTATIC HYPERTROPHY FOLLOWED BY 4-5 DAYS OF PROSTATIC SYMPTOMS AND TWO SYNCOPAL EPISODES. CT SHOWED A LEAKING ANEURYSM AND GAS AROUND THE STENT GRAFT. THE PT EXPIRED BEFORE ANY INTERVENTION WAS TAKEN ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 06441548

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O