BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1241519 · Received November 21, 2008

    Report

    Report Number
    2953161-2008-00396
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 21, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. DEVICE ALSO INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    IN 2008, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. FINAL ANGIO SHOWED NO ANEURYSMAL OCCLUSION. THE PRESENCE OF TYPE 2 ENDOLEAKS FROM LUMBARS AND A PROXIMAL TYPE I ENDOLEAK WERE NOTED IN FINAL ANGIO. AT THIS POINT, THE PHYSICIAN ENDED THE PROCEDURE. A CT ON THE NEXT DAY, REVEALED COMPLETE PROXIMAL INVAGINATION AND FILLING OF ANEURYSMAL SAC FROM THE PROXIMAL END OF THE DEVICE. THE DEVICES WERE SUCCESSFULLY EXPLANTED ON THREE WEEKS PRIOR TO ORIGINAL DATE, AND PT WAS CONVERTED TO SURGICAL REPAIR. THE DEVICES AND IMAGES HAVE BEEN RETURNED TO GORE FOR EVAL. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 06260066

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention