BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3313749 · Received August 20, 2013

    Report

    Report Number
    3008011247-2013-00027
    Event Type
    Other
    Date Received
    August 20, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 22, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE TRIVASCULAR OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. AFTER SUCCESSFUL DEPLOYMENT OF THE AORTIC BODY GRAFT, THE PHYSICIAN CANNULATED WHAT WAS BELIEVED TO BE THE CONTRALATERAL LEG OF THE AORTIC BODY GRAFT AND DEPLOYED THE CONTRALATERAL ILIAC LIMB GRAFT. FOLLOWING DEPLOYMENT OF THE IPSILATERAL ILIAC LIMB GRAFT, IT WAS CONFIRMED THAT BOTH ILIAC LIMB GRAFTS WERE INADVERTENTLY DEPLOYED INTO THE IPSILATERAL LEG OF THE AORTIC BODY GRAFT. AN ILIAC LIMB GRAFT WAS THEN DEPLOYED INTO THE CONTRALATERAL LEG OF THE AORTIC BODY GRAFT AND BALLOON-EXPANDABLE STENTS WERE IMPLANTED IN THE IPSILATERAL SIDE TO OPEN ONE OF THE IPSILATERAL ILIAC LIMB GRAFTS AND COLLAPSE THE OTHER ILIAC LIMB GRAFT. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED, WITH NO FURTHER PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403148 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS042313-13

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other