BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 5038953 · Received August 28, 2015

    Report

    Report Number
    3008011247-2015-00096
    Event Type
    Death
    Date Received
    August 28, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 29, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2980E1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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. FOLLOWING THE SUCCESSFUL IMPLANTATION OF THE DEVICE AND ANEURYSM EXCLUSION, THE PATIENT'S LEFT FOOT HAD NO PULSE, BELIEVED TO BE DUE TO A POTENTIAL BLOOD CLOT. BECAUSE MULTIPLE ATTEMPTS TO RESOLVE THE BLOOD CLOT WERE UNSUCCESSFUL AND RESULTED IN PROLONGED PATIENT ANESTHESIA TIME (9 HOURS), THE PHYSICIAN ELECTED TO PERFORM A SURGICAL BYPASS. BASED ON A FOLLOW-UP COMMUNICATION RECEIVED FROM THE PHYSICIAN, THE PATIENT LATER EXPIRED THAT NIGHT FOLLOWING THE BYPASS PROCEDURE. AS OF THE DATE OF THIS REPORT, THE EXACT CAUSE OF DEATH HAS NOT BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571424 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-E FS022015-10 M701TVAB2980E1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death GORE AORTIC CUFF (28MM)