BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3953969 · Received July 23, 2014

    Report

    Report Number
    3008011247-2014-00051
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 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

    DELIVERY SYSTEM NOT RETURNED.

    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 STENT GRAFT WAS DEPLOYED AS EXPECTED, AND POLYMER FILL WAS INITIATED. DURING THE POLYMER FILLING OF THE GRAFT, THE POLYMER SYRINGE WAS OBSERVED TO HAVE EMPTIED AT AN UNKNOWN TIME POINT IN THE POLYMER FILL PROCESS. THE PATIENT EXPERIENCED HYPOTENSION WHICH WAS STABILIZED FOLLOWING TREATMENT FOR A RADIOCONTRAST AGENT ALLERGY IN ACCORDANCE WITH THE DEVICE IFU. THE AORTIC BODY GRAFT FILL CHANNELS REMAINED FILLED WITH POLYMER, AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE END OF THE CASE. 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
    431691 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-E FS032514-20

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention