BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2162136 · Received July 7, 2011

    Report

    Report Number
    2953161-2011-00149
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    February 21, 2009
    Report Date
    July 7, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    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. PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN PATIENT POPULATIONS WITH PSEUDOANEURYSM RESULTING FROM PREVIOUS GRAFT PLACEMENT.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN AORTO-UNI-ILIAC AND FEMORO-FEMORAL BYPASS AT ANOTHER FACILITY USING NON-GORE DEVICES. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY THAT REVEALED BILATERAL PSEUDOANEURYSMS RESULTING FROM THE FIRST SURGERY. ON (B)(6) 2008, THE PATIENT UNDERWENT REPAIR OF A RIGHT FEMORAL PSEUDOANEURYSM AND WAS IMPLANTED WITH A CONTRALATERAL LEG COMPONENT. ON (B)(6) 2009, THE PATIENT UNDERWENT REPAIR OF A LEFT FEMORAL PSEUDOANEURYSM AND WAS IMPLANTED WITH A CONTRALATERAL LEG COMPONENT. ON AN UNKNOWN DATE, A FOLLOW-UP COMPUTED TOMOGRAPHY REVEALED THROMBOSIS IN THE CONTRALATERAL LEG COMPONENT IMPLANTED ON (B)(6) 2009. ON (B)(6) 2009, THE CONTRALATERAL LEG COMPONENT WAS EXPLANTED AND THE PATIENT UNDERWENT OPEN REPAIR USING A HEMASHIELD GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG325 06340997

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R COREG| LEVOTHYROXINE| CRESTOR| DIOVAN| VICODIN