BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 6082081 · Received November 7, 2016

    Report

    Report Number
    3008011247-2016-00118
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2380J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION IX ABDOMINAL STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, IT WAS OBSERVED THAT THE SEALING RINGS AND CONTRALATERAL GRAFT LEG PARTIALLY FILLED WITH POLYMER IN THE PRESENCE OF SIGNIFICANT JUXTARENAL ANGULATION. THE AUTO INJECTOR WAS DISCONNECTED AND RE-CONNECTED WITH NO CHANGE IN THE POLYMER FILL. A BALLOON EXPANDABLE STENT WAS DEPLOYED WITHIN THE AORTIC BODY STENT GRAFT, LANDING BELOW THE INTENDED LANDING ZONE. THE PATIENT WAS CONVERTED TO AUI WITH A FEM-FEM BYPASS, FOLLOWED BY THE PLACEMENT OF AN ILIAC LIMB EXTENSION AND AORTIC CUFF SUCCESSFULLY EXCLUDING THE ANEURYSM. 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
    733513 OVATION IX ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-J FS021616-09 M701TVAB2380J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AORTIC CUFF| ILIAC LIMB EXTENSION| PALMAZ STENT