BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4429768 · Received January 17, 2015

    Report

    Report Number
    3008011247-2015-00008
    Event Type
    Injury
    Date Received
    January 17, 2015
    Report Date
    December 18, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE; REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR FOLLOW-UP ON AN UNKNOWN DATE PRESENTING WITH BILATERAL ILIAC LIMB OCCLUSION AND WAS SUBSEQUENTLY CONVERTED TO OPEN SURGICAL REPAIR TO PERFORM AN AXIAL-FEMORAL BYPASS. THE PRE-OPERATIVE CT IMAGING INDICATED THAT THE PATIENT HAD NARROW NATIVE AORTIC BIFURCATION AND SIGNIFICANT BILATERAL CALCIUM AND ANEURYSMAL COMMON ILIAC VESSELS; IT COULD NOT BE DETERMINED WHETHER THESE ANATOMICAL CONDITIONS FACTORED INTO THE OCCLUSION. 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
    42492 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-E FS030513-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SURGICAL GRAFT