BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 6206285 · Received December 27, 2016

    Report

    Report Number
    3008011247-2016-00137
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2680J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. IT WAS NOTED THAT THE ACCESS VESSELS WERE CHALLENGING. UPON DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, THE POLYMER SYRINGE EMPTIED AND THE PATIENT EXPERIENCED TRANSIENT HYPOTENSION. THE HYPOTENSION WAS TREATED IN ACCORDANCE WITH THE IFU AND THE PATIENT WAS STABILIZED INTRA-OPERATIVELY. TWO COVERED STENTS WERE IMPLANTED BILATERALLY WITHIN THE AORTIC BODY STENT GRAFT EXTENDING UP TO THE SECONDARY SEALING RING TO MAINTAIN LUMENAL PATENCY IN THE PRESENCE OF OBSERVED NARROWING WITHIN THE AORTIC BODY STENT GRAFT. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE IMPLANT PROCEDURE. 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
    857124 OVATION IX ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-I FS032216-12 M701TVAB2680J1

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention COVERED STENTS (X2)