BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2893963 · Received December 21, 2012

    Report

    Report Number
    2953161-2012-00216
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 ENDOPROSTHESES. IT APPEARED THE MIGRATION MAY HAVE BEEN DUE TO A TORTUOUS AORTIC NECK WITH AN APPROXIMATELY 60 DEGREE ANGLE. ON (B)(6) 2012, THE PT UNDERWENT A PROCEDURE TO ADDRESS TRUNK MIGRATION, WHERE FOUR AORTIC EXTENDERS WERE ADDED PROXIMALLY. 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 05268360

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R