BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1944444 · Received December 28, 2010

    Report

    Report Number
    2953161-2010-00230
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    September 7, 2010
    Report Date
    December 27, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ADD'L DEVICES: IMPLANTED/EXPLANTED: PXT261418/06774405, PXC141400/7082338, PXC141200/7135893, PXC141000/7132353, PXL161007/7135543, PXL161007/7135544, PXA280300/7071600, PXA280300/7110727, PXA260300/7116881, PXA260300/7116882.

    Description of Event or Problem · 1

    ON (B)(6), 2009, THE PT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSMS, AND WAS IMPLANTED WITH 11 GORE EXCLUDER AAA ENDOPROSTHESES. PREOPERATIVELY, THE PT UNDERWENT COIL EMBOLIZATION OF BOTH INTERNAL ILIAC ARTERIES AND A BARE STENT WAS IMPLANTED IN THE EXTERNAL ILIAC ARTERIES. ON (B)(6), 2010, THE PT UNDERWENT A F/U COMPUTED TOMOGRAPHY WHICH REVEALED A TYPE III ENDOLEAK BETWEEN TWO OF THE AORTIC EXTENDER COMPONENTS. ON (B)(6), 2010, THE PT UNDERWENT A REINTERVENTION WHERE IT WAS ATTEMPTED TO IMPLANT A ZENITH GRAFT TO TREAT THE TYPE III ENDOLEAK; HOWEVER, THE DELIVERY CATHETER WAS UNABLE TO REACH PROPER POSITION AND THE DEVICE WAS NOT IMPLANTED. ON (B)(6), 2010, THE PT WAS CONVERTED TO OPEN REPAIR WHERE ALL DEVICES WERE EXPLANTED AND DISCARDED. THE PT TOLERATED THE PROCEDURE.

    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 WLG425 06730815

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R