BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2202335 · Received August 8, 2011

    Report

    Report Number
    2953161-2011-00174
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 3, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. AFTER A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 WAS IMPLANTED, IT WAS THOUGHT THAT CANNULATION HAD BEEN OBTAINED; HOWEVER, THE CONTRALATERAL LEG COMPONENT WAS DEPLOYED OUTSIDE OF THE GATE. THE PT UNDERWENT AN AORTA UNI-ILIAC WITH AN ADD'L GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 AND A FEMORAL-FEMORAL BYPASS WITH A GORE PROPATEN VASCULAR GRAFT. 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 9085952

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R COUMADIN| GEMFIBROZIL| ISOSORBIDE| COREG| NITROGLYCERIN| PLAVIX| PROMETHAZINE| CLARITIN| RESTORIL| PROAIR| PACERONE| LOVAZA| ENALAPRIL