BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3898649 · Received June 26, 2014

    Report

    Report Number
    3008011247-2014-00041
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    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 AND ILIAC LIMB STENT GRAFTS WERE DEPLOYED AS PLANNED. THE FINAL ANGIOGRAM SHOWED A TYPE IA ENDOLEAK WHICH DID NOT RESOLVE WITH BALLOONING. PRE-CASE CT IMAGING INDICATED SIGNIFICANT THROMBUS IN THE AORTIC SEAL ZONE; HOWEVER, IT IS UNKNOWN WHETHER THIS CONTRIBUTED TO THE UNRESOLVED ENDOLEAK. THE PATIENT HAS A HISTORY OF RENAL INSUFFICIENCY; THEREFORE, THE PHYSICIAN ELECTED TO MONITOR THE PATIENT AND PERFORM A FOLLOW-UP CT WHEN THE PATIENT CAN TOLERATE THE IMAGING. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374623 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-E FS110812-05

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other