BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 5022179 · Received August 21, 2015

    Report

    Report Number
    3008011247-2015-00093
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB3480E1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, THE STENT GRAFT WAS INADVERTENTLY DEPLOYED ABOVE THE INTENDED LANDING ABOVE THE LEFT INFERIOR RENAL ARTERY. A BALLOON EXPANDABLE STENT WAS PLACED IN THE RENAL ARTERY MAINTAIN PATENCY. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE IMPLANT PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554164 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS030215-29 M701TVAB3480E1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other OMNILINK STENT