BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3133203 · Received May 24, 2013

    Report

    Report Number
    3008011247-2013-00011
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE TRIVASCULAR OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. FOLLOWING ROUTINE INJECTION OF FILL POLYMER INTO THE GRAFT INFLATION CHANNELS, THE PROXIMAL RING OF THE AORTIC BODY GRAFT WAS BALLOONED WITH A COMPLIANT RELIANT BALLOON JUST PRIOR TO DEMATE OF THE DELIVERY SYSTEM. UPON BALLOONING, A BREACH OF THE SECONDARY SEALING RING WAS NOTED ON ANGIOGRAM, POSSIBLY DUE TO THE PENETRATION OF AN ADJACENT CALCIUM SHELF INTO THE GRAFT. THE PATIENT BEGAN TO EXPERIENCE HYPOTENSION AND WAS TREATED WITH NEO-SYNEPHERINE, STABILIZING THE PATIENT'S BLOOD PRESSURE IN APPROXIMATELY 20 MINUTES. THE PROCEDURE WAS COMPLETED WITH DEPLOYMENT OF THE TWO ILIAC LIMBS AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231270 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS092712-04

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention