BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 6183476 · Received December 16, 2016

    Report

    Report Number
    3008011247-2016-00136
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2680J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON ADVANCING THE AORTIC BODY DELIVERY SYSTEM IN THE PRESENCE OF SIGNIFICANT CALCIUM, THE PHYSICIAN ENCOUNTERED RESISTANCE FOLLOWED BY AN OBSERVED RUPTURE OF THE ILIAC ARTERY. THE PHYSICIAN ELECTED TO ABORT THE EVAR PROCEDURE, AND THE ILIAC ARTERY WAS SURGICALLY REPAIRED SUCCESSFULLY RESOLVING THE RUPTURE. 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
    833957 OVATION IX ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-J FS040516-43 M701TVAB2680J1

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention