BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1210323 · Received October 21, 2008

    Report

    Report Number
    2954310-2008-81681
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    September 1, 2000
    Report Date
    October 21, 2008
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE PT'S FAMILY THE ANEURYSM SAC DID NOT CLOSE TIGHTLY AROUND THE ENDOGRAFT FOLLOWING IMPLANT. DESPITE THIS, THERE WAS NO ENDOLEAKS OBSERVED. THIS PT HAS SINCE PASSED AWAY DUE TO CANCER. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFO, HOWEVER, AS OF TODAY NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS 204221511-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R