BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 6115414 · Received November 19, 2016

    Report

    Report Number
    3008011247-2016-00126
    Event Type
    Injury
    Date Received
    November 19, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2380J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, THE DEVICE WAS INADVERTENTLY POSITIONED ABOVE THE INTENDED LANDING ZONE PARTIALLY COVERING THE RENAL ARTERIES. BILATERAL RENAL STENTS WERE PLACED TO MAINTAIN PATENCY AND BLOODFLOW. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK. A RE-INTERVENTION IS PLANNED AT A LATER DATE TO TREAT THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766465 OVATION IX ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-J FS033116-55 M701TVAB2380J1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other RENAL STENT (X2)