BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2111767 · Received May 25, 2011

    Report

    Report Number
    2953161-2011-00123
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 24, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED. THE REVIEW OF THE MFG PAPERWORK HAS NOT BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011, AN INTERVENTION OCCURRED TO TREAT INDETERMINATE ANEURYSM GROWTH. INITIAL ANGIOGRAPHY SHOWED NO APPARENT ENDOLEAK. A DECISION WAS MADE TO TREAT POSSIBLE ENDOTENSION. THE PREVIOUSLY PLACED GRAFTS WERE RELINED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. COMPLETION ANGIOGRAPHY SHOWED NO APPARENT ENDOLEAK. THE PT TOLERATED THE PROCEDURE WELL.

    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 03684173

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R ACTONEL| BONIVA| CONCOMITANT MEDICATIONS INCLUDED:| ISOSORBIDE| CARBIDOPA/LEVO| ATENOLOL| CALCIUM| NORTRYPTYLINE| SIMVASTATIN| ZIPSOR| DONEPEZIL| NITROGLYCERIN