BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1180509 · Received September 26, 2008

    Report

    Report Number
    2954310-2008-81671
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    October 25, 2000
    Report Date
    September 25, 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

    APPROX ONE WEEK POST IMPLANT, THIS PT ALLEGES DIFFICULTY WALKING. A DOPPLER SCAN WAS PERFORMED AND IDENTIFIED THAT THE LEFT SIDE OF THE GRAFT WAS TWISTED, AND THERE WAS CLOTTING INSIDE. THE PT UNDERWENT A RIGHT TO LEFT CROSSOVER BYPASS PROCEDURE. THE PT STATED THAT HE STILL HAS DIFFICULTY WALKING, HOWEVER, AT HIS LAST FOLLOW-UP APPOINTMENT, HE WAS TOLD THAT HIS ANEURYSM HAD DECREASED IN SIZE. THE PT IS NO LONGER BEING FOLLOWED BY A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS 13434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention