BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3922339 · Received July 9, 2014

    Report

    Report Number
    3008011247-2014-00044
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    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 AND ILIAC LIMB STENT GRAFTS WERE POSITIONED AND DEPLOYED AS EXPECTED. A REVIEW OF THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK WHICH WAS NOT RESOLVED WITH BALLOONING. THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK UNTIL THE ONE MONTH FOLLOW-UP. 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
    399522 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS110613-03

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other ILIAC STENT (8X39MM)