BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2885079 · Received December 10, 2012

    Report

    Report Number
    2953161-2012-00208
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    December 19, 2008
    Report Date
    November 14, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2003, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER BIFURCATED ENDOPROSTHESES, AND WAS LATER FOUND TO HAVE TYPE 1B AND II ENDOLEAKS WITH ANEURYSM ENLARGEMENT. THE PT WAS ALSO REPORTED TO HAVE ENDOTENSION, BUT THIS COULD NOT BE CONFIRMED WITH THE AVAILABLE INFO. ON (B)(6) 2008, THE PT UNDERWENT ANOTHER PROCEDURE. THE EXISTING DEVICES WERE EXTENDED PROXIMALLY AND DISTALLY ON BOTH SIDES.

    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 022421205

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R URSODIOT| LISINOPRIL| AMIODARONE| SIMVASTATIN| HYDROYUREA| DIGOXIN| COREG| ALBUMEX| ATROVENT| PROVIGIL| ARANESP| (B)(4)| SPIRONOLACTONE| CABG| ASPIRIN