BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3161797 · Received June 6, 2013

    Report

    Report Number
    3008011247-2013-00012
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    TRIVASCULAR INC
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. AFTER SUCCESSFUL STENT GRAFT DEPLOYMENT AND POLYMER FILL, THE PHYSICIAN GAINED ACCESS TO THE AORTIC BODY CONTRALATERAL GATE. THE PHYSICIAN BALLOONED THE PROXIMAL SEAL ZONE PRIOR TO THE MINIMUM WAIT TIME STATED IN THE IFU. THE PT EXPERIENCED HYPOTENSION AND A DROP IN BLOOD PRESSURE WHICH WAS TREATED AS RECOMMENDED IN THE IFU, AND THE PT WAS STABILIZED. IT WAS NOTED THAT THE GRAFT SEALING RINGS APPEARED TO CONTAIN LESS POLYMER AS COMPARED TO BEFORE THE BALLOONING OCCURRED; THEREFORE, A PALMAZ STENT WAS PLACED AT THE PROXIMAL SEAL ZONE. THE ILIAC LIMBS WERE IMPLANTED AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251621 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR INC TV-AB2680-D FS121712-09

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention