BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION IX ILIAC LIMB STENT GRAFT SYSTEM

    MDR report key: 5004954 · Received August 14, 2015

    Report

    Report Number
    3008011247-2015-00089
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 16, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVIL1416140I1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM AT OVATION IX ILIAC STENT GRAFTS WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS READMITTED TO THE HOSPITAL 3 WEEKS POST-OP WITH A COMPLETE OCCLUSION OF THE LEFT ILIAC LIMB STENT GRAFT IN THE PRESENCE OF SIGNIFICANT JUXTARENAL AORTIC ANGULATION. A RE-INTERVENTION WAS COMPLETED TWO DAYS LATER IN WHICH A FEM-FEM BYPASS WAS PERFORMED TO SUCCESSFULLY RESTORE BLOOD FLOW TO THE OCCLUDED ILIAC ARTERY. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540508 OVATION IX ILIAC LIMB STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-IL1416140-I FS022015-65 M701TVIL1416140I1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention BYPASS GRAFT