BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 5089619 · Received September 18, 2015

    Report

    Report Number
    3008011247-2015-00109
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 21, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1.5 MONTH FOLLOW-UP CT SHOWED THE PRESENCE OF A POTENTIAL TYPE III ENDOLEAK AT THE JUNCTION OF THE AORTIC BODY AND ILIAC LIMB OVERLAP. 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
    619224 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-E FS013115-08

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other