BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4123429 · Received September 26, 2014

    Report

    Report Number
    3008011247-2014-00074
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT DURING ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL STENT WAS INADVERTENTLY DEPLOYED DISTAL TO THE INTENDED LANDING ZONE AND COULD NOT BE FULLY REPOSITIONED. DURING THE ATTEMPTS TO REPOSITION THE STENT GRAFT, THE DELIVERY SYSTEM WAS FULLY ROTATED AND PUSHED PROXIMALLY, CAUSING DAMAGE AT THE DELIVERY SYSTEM/GRAFT JUNCTION, AS EVIDENCED BY THE PRESENCE OF BLOOD IN THE FILL TUBE OF THE CATHETER HANDLE. THEREFORE, THE PHYSICIAN ELECTED NOT TO FILL THE GRAFT WITH POLYMER. UPON WITHDRAWAL OF THE DELIVERY SYSTEM, THE CATHETER NOSECONE WAS OBSERVED TO BE DISCONNECTED DUE TO THE SIGNIFICANT DEVICE MANIPULATION BUT REMAINED ON THE GUIDEWIRE; IT WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT. THE IPSILATERAL LEG WAS IMPLANTED; HOWEVER, IMPLANTATION OF THE CONTRALATERAL LEG COULD NOT BE COMPLETED DUE TO VISUALIZATION DIFFICULTIES. A RE-INTERVENTION WAS PERFORMED TO PLACE A AUI CONVERTER, AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602239 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-E FS102813-36

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other