BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1013097 · Received March 14, 2008

    Report

    Report Number
    2953161-2008-00042
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    August 2, 2005
    Report Date
    March 13, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPER VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2005, A PATIENT PRESENTED WITH AN ACTIVE RUPTURED ANEURYSM. THE PATIENT WAS TREATED ENDOLUMINALLY WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TRUNK - IPSILATERAL LEG COMPONENTS AND A CONTRALATERAL LEG COMPONENT. FINAL ANGIOGRAM REVEALED A TYPE I ENDOLEAK AND THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. ON THE FOLLOWING MONTH, THE PATIENT WAS TREATED WITH TWO AORTIC EXTENDER COMPONENTS TO TRY AND RESOLVE THE TYPE I ENDOLEAK. THE TYPE I ENDOLEAK DID NOT SEAL. THE PHYSICIAN CONVERTED TO OPEN REPAIR. DUE TO SEVERE COMORBIDITIES, THE PATIENT EXPIRED.

    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 03577884

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R