BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1132143 · Received August 22, 2008

    Report

    Report Number
    2953161-2008-00218
    Event Type
    Injury
    Date Received
    August 22, 2008
    Report Date
    August 21, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2003, THE PATIENT WAS TREATED WITH A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. ACCORDING TO THE PHYSICIAN, THERE WERE NO COMPLICATIONS FROM THE ORIGINAL PROCEDURE AND AT DATE UNKNOWN TO THE PHYSICIAN A PROXIMAL TYPE I ENDOLEAK WAS NOTICED WITH THE ANEURYSM ENLARGING OVER 1 CM. THE PATIENT IS DOING FINE AND HAS REFUSED ANY FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 021211101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other