BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3995833 · Received August 8, 2014

    Report

    Report Number
    3008011247-2014-00059
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE AORTIC BODY WAS ADVANCED PERCUTANEOUSLY AND POSITIONED AND DEPLOYED AS EXPECTED. DURING POLYMER FILL OF THE AORTIC BODY GRAFT, MINIMAL POLYMER WAS OBSERVED IN THE GRAFT FILL CHANNELS AND THE FILL POLYMER SYRINGE WAS OBSERVED TO BE EMPTY. THE PATIENT EXPERIENCED HYPOTENSION, WHICH WAS SUCCESSFULLY TREATED PER THE RECOMMENDATIONS IN THE DEVICE IFU. DURING PLACEMENT OF A PALMAZ STENT IN THE PROXIMAL SEAL ZONE TO ACHIEVE SEAL, THE AORTIC BODY STENT GRAFT AND PALMAZ STENT WERE INADVERTENTLY DISPLACED PROXIMALLY DURING BALLOONING, COVERING THE RENAL ARTERIES AND WERE SUCCESSFULLY REPOSITIONED DISTALLY BELOW THE RENAL ARTERIES. DUE TO THE INABILITY TO VISUALIZE THE AORTIC BODY GRAFT, THE PHYSICIAN ELECTED TO ABORT THE CASE WITHOUT IMPLANTING ILIAC LIMBS AND THE ANEURYSM WAS NOT EXCLUDED. AN EXAMINATION OF THE RETURNED DELIVERY SYSTEM DID NOT REVEAL ANY DEFECTS IN THE POLYMER FLOW CHANNEL; THE IMPLANT REMAINS IMPLANTED AND THEREFORE IS NOT AVAILABLE FOR EXAMINATION. 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
    471608 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-D FS032914-12

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PALMAZ STENT