BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4889524 · Received July 2, 2015

    Report

    Report Number
    3008011247-2015-00061
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING BALLOONING. A RE-INTERVENTION WAS PERFORMED ON THE SAME DAY TO PLACE AN AORTIC CUFF WHICH DID NOT RESOLVE THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430640 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2080-D FS091814-05

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention COOK AORTIC CUFF