BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1941782 · Received December 21, 2010

    Report

    Report Number
    2017233-2010-00567
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 17, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES ,INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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), 2009, THIS PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT AND CONTRALATERAL LEG COMPONENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2010, THE PT WAS BEING SEEN FOR AORTIC ARTERY STENOSIS, AND AN ARTERIOGRAM DEMONSTRATED THROMBUS IN THE IPSILATERAL LIMB OF THE TRUNK-IPSILATERAL LEG COMPONENT, REPORTEDLY DUE TO OUTFLOW ISSUES. THE FSA REPORTED THE IPSILATERAL LIMB OF THE TRUNK-IPSILATERAL LEG COMPONENT IS COMPLETELY OCCLUDED. THE PT IS ASYMPTOMATIC AT THIS TIME. NO FURTHER ADVERSE EVENTS WERE REPORTED, AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PT.

    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 ,INC. WLG425 06585433

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other PLAVIX| OMEPRAZOLE| SIMVASTATIN| NITROGLYCERIN| VITAMIN D