BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3895732 · Received June 25, 2014

    Report

    Report Number
    3008011247-2014-00040
    Event Type
    Death
    Date Received
    June 25, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RELEASED FROM THE SITE.

    Description of Event or Problem · 1

    THE SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. THE AORTIC BODY GRAFT WAS PLACED DISTAL TO THE INTENDED SEAL ZONE IN A LOCATION WHERE THE AORTIC DIAMETER WAS LARGER THAN PLANNED, WHICH RESULTED IN A TYPE IA ENDOLEAK. A PALMAZ STENT WAS IMPLANTED IN THE SEAL ZONE USING A NON-COMPLIANT BALLOON THAT WAS LARGER THAN THE AORTIC VESSEL DIAMETER. FOLLOWING BALLOON DILATATION OF THE PALMAZ STENT, IT WAS NOTED THAT THE PALMAZ STENT WAS DAMAGED AND THE AORTA WAS PERFORATED PROXIMAL TO THE RENAL ARTERIES. THE PATIENT WAS CONVERTED TO OPEN SURGERY AND EXPIRED TWO HOURS FOLLOWING THE CONVERSION; THE PATIENT WAS NOT A CANDIDATE FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371643 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-D FS100713-41

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death PALMAZ STENT