BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME STENT GRAFT SYSTEM

    MDR report key: 3942627 · Received July 17, 2014

    Report

    Report Number
    3008011247-2014-00049
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. DURING INJECTION OF THE FILL POLYMER INTO THE AORTIC BODY STENT GRAFT, IT WAS OBSERVED THAT FILL POLYMER WAS NOT FILLING THE GRAFT. AFTER ATTEMPTS TO FILL THE GRAFT WERE UNSUCCESSFUL, AN OBSTRUCTION WAS NOTED IN THE DELIVERY SYSTEM POLYMER FLUID PATH. AN ILIAC LIMB STENT GRAFT WAS DEPLOYED INTO THE IPSILATERAL LEG OF THE AORTIC BODY, REQUIRING ADDITIONAL LIMBS TO BRIDGE THE LENGTH AND SEAL INTO THE COMMON ILIAC ARTERY. BECAUSE THE CONTRALATERAL LEG OF THE GRAFT APPEARED CLOSED DURING ANGIOGRAM REVIEW, THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO AUI AND PERFORM A FEM-FEM CROSSOVER. THE CASE CONCLUDED AFTER APPROXIMATELY 7 HOURS; A REVIEW OF THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE 1A ENDOLEAK. THE PHYSICIAN PLANS TO MONITOR THE ENDOLEAK AND TO TREAT THE ENDOLEAK AT A LATER DATE. THE PATIENT WAS REPORTED AS DOING WELL AFTER THE CASE. A REVIEW OF THE RETURNED DELIVERY SYSTEM CONFIRMED AN OBSTRUCTION IN THE POLYMER FLUID PATH DUE TO A KINK IN THE TUBING, POSSIBLY INHIBITING THE FLOW OF POLYMER TO THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418698 OVATION PRIME STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS121613-09

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention AORTO-UNI ILIAC GRAFT