BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1071423 · Received July 8, 2008

    Report

    Report Number
    2017233-2008-00367
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 11, 2008
    Report Date
    July 7, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    AS REPORTED, ON JULY 5, 2005, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. IN 2005, IMAGING DEMONSTRATED THE DISTAL LIMB OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS INFOLDED ON ITSELF. IN 2008, THE PATIENT UNDERWENT A RE-INTERVENTION IN WHICH THE TRUNK-IPSI LIMB WAS RE-OPENED BY RIGOROUS BALLOONING AND AN ILIAC EXTENDER WAS IMPLANTED WITHIN THE LIMB. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES, INC WLG325 03713388

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention