BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4900663 · Received July 8, 2015

    Report

    Report Number
    3008011247-2015-00063
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RELEASED FROM THE SITE.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IMAGING PERFORMED INTRAOPERATIVELY AND AT 30-DAY FOLLOW-UP INDICATED THAT THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. AT 42 DAYS POST-OP, THE PATIENT PRESENTED TO THE HOSPITAL WITH CARDIOPULMONARY ARREST. ANGIOGRAPHIC IMAGING SHOWED BLOOD SURROUNDING THE LEFT ILIAC LIMB STENT GRAFT INDICATIVE OF A RUPTURE OF THE LEFT COMMON ILIAC ARTERY. A RE-INTERVENTION WAS COMPLETED ON THE SAME DAY TO PLACE AN ADDITIONAL ILIAC LIMB STENT GRAFT TO EXCLUDE THE RUPTURE; HOWEVER, THE PATIENT UNDERWENT CARDIOPULMONARY ARREST AND EXPIRED ON THE SAME DAY FOLLOWING THE RE-INTERVENTION. PRE-OPERATIVE IMAGING SHOWED THE PRESENCE OF A PRE-EXISTING ANEURYSMAL LEFT COMMON ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443501 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-IL1422140-E FS061214-63

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R GORE ILIAC LIMB