BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1180503 · Received September 26, 2008

    Report

    Report Number
    2954310-2008-81667
    Event Type
    Injury
    Date Received
    September 26, 2008
    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

    ACCORDING TO THE PT, FOLLOWING THE IMPLANT PROCEDURE, THIS PT COULD NOT WALK FOR MORE THAN ONE BLOCK WITHOUT HAVING TO SIT DOWN. IT WAS LATER IDENTIFIED THAT THIS PT HAD HEART ISSUES AS WELL AS A LEFT FEMORAL ARTERY TEAR. THE PT UNDERWENT SEVERAL SURGICAL PROCEDURES TO REPAIR HIS TORN LEFT FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS 13431

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening