BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2801471 · Received October 11, 2012

    Report

    Report Number
    2953161-2012-00179
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 17, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG RECORDS REVIEW VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THE PT HAS SINCE EXPERIENCED APPROX 1 CM OF ANEURYSM ENLARGEMENT, AND ON (B)(6) 2012 SHE UNDERWENT ANOTHER PROCEDURE EXTENDING THE CONTRALATERAL LEG WITH AN ILIAC EXTENDER, TO TREAT A DISTAL TYPE I ENDOLEAK. THE PT TOLERATED THE PROCEDURE, AND IT APPEARED TO RESOLVE THE DISTAL ENDOLEAK.

    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 05441227

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R HYDROCHLOROTHIAZIDE| NIFEDIPINE| ECOTRIN| AORTIC VALVE REPLACEMENT| TRICOR