BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4923331 · Received July 17, 2015

    Report

    Report Number
    3008011247-2015-00070
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 18, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE TWO YEAR FOLLOW-UP CT IMAGING SHOWED THE PRESENCE OF PROXIMAL MIGRATION OF THE LEFT ILIAC LIMB DUE TO THE IMPLANTATION OF A SHORTER ILIAC LIMB STENT GRAFT IN THE LEFT COMMON ILIAC ARTERY, THAT PLACED THE DISTAL END OF THE ILIAC LIMB STENT GRAFT IN A LOCATION OUTSIDE THE TREATMENT RANGE FOR IMPLANTED DEVICE. A RE-INTERVENTION IS PLANNED AT A LATER DATE TO PLACE AN ADDITIONAL ILIAC LIMB TO EXTEND THE SEAL INTO THE COMMON ILIAC ARTERY. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465368 OVATION ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-IL1422100-B FS041311-15

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention