BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3892837 · Received June 24, 2014

    Report

    Report Number
    3008011247-2014-00037
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. THE STENT GRAFT WAS POSITIONED AND DEPLOYED AS PLANNED. DURING CANNULATION OF THE CONTRALATERAL LEG OF THE GRAFT, THE GUIDEWIRE MAY HAVE WRAPPED AROUND THE AORTIC BODY DELIVERY SYSTEM CAUSING THE LEGS OF THE AORTIC BODY GRAFT TO TWIST 360 DEGREES. THE IPSILATERAL AND CONTRALATERAL ILIAC LIMBS WERE DEPLOYED SIMULTANEOUSLY IN A POSITION TO MAINTAIN FLOW TO THE LIMBS, WHICH WAS CONFIRMED BY FINAL ANGIOGRAM. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED, AND THERE WERE NO PATIENT SEQUELAE. AS OF THE DATE OF THIS REPORT, THE PATIENT IS REPORTED AS DOING WELL WITH NO SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369204 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-E FS120513-21

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other ILIAC STENT