BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4492434 · Received February 6, 2015

    Report

    Report Number
    3008011247-2015-00013
    Event Type
    Death
    Date Received
    February 6, 2015
    Date of Event
    January 9, 2015
    Report Date
    January 9, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RELEASED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC BODY WAS POSITIONED AND DEPLOYED AS EXPECTED. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK WHICH WAS NOT RESOLVED WITH INITIAL BALLOONING. THE BALLOON WAS THEN INADVERTENTLY RE-INFLATED PROXIMAL TO THE SEALING RINGS IN THE PROXIMAL STENT REGION WHICH RESULTED IN RUPTURE OF THE AORTIC VESSEL ABOVE THE RENAL ARTERIES. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR DURING WHICH THE PATIENT EXPIRED. THE PHYSICIAN DOES NOT ATTRIBUTE THE AORTIC RUPTURE TO BE A DEVICE RELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86053 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS081314-42

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death