BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1031572 · Received April 18, 2008

    Report

    Report Number
    2953161-2008-00077
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 14, 2008
    Report Date
    April 17, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 SPECS. PLEASE NOTE ATTACHED LIST OF ADDITIONAL DEVICE USED AND INVOLVED IN THIS EVENT; ILIAC EXTENDER COMPONENT (PXL161207/05099349).

    Description of Event or Problem · 1

    IN 2008, THE PT WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT AND TWO ILIAC EXTENDER COMPONENTS. THE TWO ILIAC EXTENDER COMPONENTS WERE COMBINED TO CREATE AN 8 CM LONG STENT, TO BE IMPLANTED ON THE CONTRALATERAL SIDE OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE IPSILATERAL LEG WAS COMPRESSED BY THE ILIAC EXTENDER. AS REPORTED, THE DIAMETER OF THE TERMINAL AORTA OF THIS PT WAS 15MM X 18MM. THE PHYSICIAN USED A PTA BALLOON TO EXPAND THE COMPRESSED PART OF THE IPSILATERAL LEG. THE ANGIOGRAM CONFIRMED BOTH LEGS WERE SUFFICIENTLY PATENT, AND THE PROCEDURE WAS COMPLETED. A CT SCAN ON THREE DAYS LATER REVEALED THAT THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS COMPRESSED AGAIN. ON THE NEXT DAY, A PALMAZ STENT WAS INSERTED INTO THE COMPRESSED PART OF THE IPSILATERAL LEG OF THE RIGHT LIMB. A SECOND PALMAZ STENT WAS INSERTED IN THE LEFT LIMB. THE PT WAS DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 05250195

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other