BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3576617 · Received January 2, 2014

    Report

    Report Number
    3008011247-2014-00002
    Event Type
    Death
    Date Received
    January 2, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE PHYSICIAN HAD DIFFICULTIES WITH THE ACCESS DEVICE, GAINING ACCESS AFTER APPROX 1 HOUR. THE AORTIC BODY GRAFT WAS SUCCESSFULLY DEPLOYED, AND AFTER CANNULATING THE CONTRALATERAL GATE OF THE AORTIC BODY, THE PHYSICIAN LOST GUIDEWIRE ACCESS, REQUIRING A BRACHIAL APPROACH DUE TO THE DIFFICULTIES REGAINING ACCESS. THE CONTRALATERAL ILIAC LIMB WAS SUCCESSFULLY DEPLOYED THROUGH BRACHIAL ACCESS AFTER APPROX 3 HOURS. THERE WERE DIFFICULTIES WITH THE LEFT LEG CLOSURE DEVICE AND THE NEXT DAY, THE PT'S LEG HAD THROMBOSED DISTALLY. IT WAS NOTED THAT THE STENT GRAFT APPEARED FULLY PATENT, AND THE PHYSICIAN STATED THE LEFT LEG THROMBOSIS WAS DUE TO THE ACCESS CLOSURE DEVICE. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2013 TO REMOVE THE THROMBUS IN THE LEFT LEG AND THE PT EXPIRED THE SAME DAY FOLLOWING THE RE-INTERVENTION. THE SITE STATED THIS WAS THE RESULT OF A POST-OPERATIVE GROIN COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-E FS083013-30

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death