BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2626355 · Received June 20, 2012

    Report

    Report Number
    2017233-2012-00423
    Event Type
    Death
    Date Received
    June 20, 2012
    Date of Event
    May 26, 2012
    Report Date
    May 26, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES: 9296213/PXA230300, 9581375/PXC141000, 9689328/PXA260300, 9689323/PXA260300, 8200603/PXA260300.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PATIENT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS ONLY 6 TO 8 MM AND HEAVILY CALCIFIED. A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 WAS ADVANCED, AND THE DEPLOYMENT KNOB WAS RELEASED. IN ERROR, THE DELIVERY CATHETER WAS PULLED COMPLETELY OUT OF THE PATIENT, CAUSING THE CONSTRAINING SLEEVE SUTURES TO SEVER AND THE DEVICE TO DEPLOY AND PULL DOWN APPROXIMATELY 2 CM. FOUR AORTIC EXTENDERS WERE ADDED; HOWEVER, A PROXIMAL TYPE I ENDOLEAK WAS PRESENT. ON (B)(6) 2012, THE PATIENT UNDERWENT A SNORKEL PROCEDURE USING VIABAHN DEVICES. THE PREVIOUSLY IMPLANTED GORE EXCLUDER AAA ENDOPROSTHESIS WAS RELINED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT, AND AN AUI AND FEM-FEM BYPASS WERE PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE PREVIOUS PROXIMAL TYPE I ENDOLEAK APPEARED TO HAVE RESOLVED. ON FRIDAY (B)(6) 2012, THE PATIENT UNDERWENT A CHOLECYSTECTOMY AND COLON RESECTION DUE TO MULTI-ORGAN FAILURE, WHICH THE PHYSICIAN SUSPECTS WAS DUE TO A CLOT OR A CALCIFIC PLAQUE SHOWERED INTO THE HEPATIC ARTERY. ON (B)(6) 2012, THE PATIENT EXPIRED DUE TO MULTI-ORGAN FAILURE.

    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 9936227

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death LIPITOR| DIGOXIN| ASPIRIN| FLOVENT| ALBUTEROL INHALER| ALLOPURINOL| MG-OX| SPIRIVA INHALER| ZEBETA| AND LEXAPRO| WARFARIN| COLCHICINE| DIOVAN| BUMETANIDE| SPIRONOLACTONE| CARTIA XT| KLOR-CON| NITROSTAT