BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1972243 · Received January 20, 2011

    Report

    Report Number
    2953161-2011-00013
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 19, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    ON (B)(6) 2010, THIS PATIENT PRESENTED FOR ABDOMINAL AORTIC ANEURYSM REPAIR UTILIZING GORE EXCLUDER AAA ENDOPROSTHESIS. THE PATIENT'S ILIAC ARTERY DIAMETERS MEASURED AT 7.5-8.5MM BILATERALLY. THE PHYSICIAN ELECTED TO IMPLANT OVERSIZED DEVICES. ON (B)(6) 2011, A REINTERVENTION WAS PERFORMED WHEREBY THE PHYSICIAN PERFORMED AN ANGIOGRAPHY AND CONFIRMED OCCLUSION OF THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE PHYSICIAN USED A TRELLIS MACHINE AND PTA BALLOONED THE LOWER QUARTER OF THE IPSILATERAL LIMB. THERE WAS SOME IMPROVEMENT BUT A CLOT REMAINED AT THE LEVEL OF THE FLOW DIVIDER, THE PATIENT WAS PLACED IN ICU AND PUT ON LYSIS THERAPY AND AN EMBOLECTOMY CATHETER. ON (B)(6) 2011, AN ADDITIONAL PROCEDURE WAS PERFORMED TO IMPLANT TWO ADDITIONAL ILIAC EXTENDER COMPONENTS AND EXTEND BOTH LIMBS OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG425 7304874

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O| R