BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 5038937 · Received August 28, 2015

    Report

    Report Number
    3008011247-2015-00095
    Event Type
    Death
    Date Received
    August 28, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2380E1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RELEASED FROM IMPLANT SITE.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC BODY DELIVERY SYSTEM WAS INADVERTENTLY RETRACTED PRIOR TO REMOVAL OF THE 3RD RELEASE WIRE KNOB, RESULTING IN DISPLACEMENT OF THE STENT GRAFT AND A TYPE IA ENDOLEAK, WHICH WAS SUCCESSFULLY RESOLVED FOLLOWING THE PLACEMENT OF A BALLOON EXPANDABLE STENT AND TWO AORTIC CUFFS IN THE SEAL ZONE, AND BILATERAL COVERED STENTS IN THE RENAL AND SUPERIOR MESENTERIC ARTERIES. BASED ON A FOLLOW-UP COMMUNICATION RECEIVED FROM THE PHYSICIAN, THE PATIENT EXPIRED TWELVE DAYS POST-OP DUE TO MESENTERIC ISCHEMIA AND BOWEL INFARCTION. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS NOT RELATED TO THE DEVICE BUT RATHER A POST-OPERATIVE COMPLICATION FROM THROMBUS DISPLACEMENT DURING THE EVAR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571422 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2380-E FS110314-06 M701TVAB2380E1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death GORE AORTIC CUFF (23MM)