BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2884987 · Received December 11, 2012

    Report

    Report Number
    2953161-2012-00209
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 13, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2004, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6), 2012, ANOTHER CONTRALATERAL LEG WAS PLACED TO ADDRESS A TYPE III ENDOLEAK. THE PT TOLERATED THE PROCEDURE, AND THE ENDOLEAK WAS RESOLVED.

    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 041101001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R LIPITOR| PLAVIX| ATENOLOL| ISOSORBIDE MONONITRATE| ASPIRIN