BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1071424 · Received July 8, 2008

    Report

    Report Number
    2017233-2008-00362
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 11, 2008
    Report Date
    July 2, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED IN THIS PATIENT AND POSSIBLY INVOLVED IN THIS EVENT: PXC161200/LOT#03505370 AND PXC161000/LOT#03608507.

    Description of Event or Problem · 1

    IN 2005, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. AS REPORTED, AT AN UNKNOWN DATE A TYPE III ENDOLEAK WAS OBSERVED ORIGINATING FROM THE LEFT COMMON ILIAC ARTERY. AS REPORTED, THE TYPE III ENDOLEAK WAS ATTRIBUTED TO IMPROPER DEVICE SEAL LENGTH. IN 2008, THIS PATIENT UNDERWENT A REINTERVENTION IN WHICH A COLLATERAL LEG COMPONENT PXC141400 WAS IMPLANTED WITHIN THE LEFT COMMON ILIAC ARTERY, SUCCESSFULLY RESOLVING THE ENDOLEAK. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG325 03437238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention