BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3593385 · Received January 6, 2014

    Report

    Report Number
    3008011247-2014-00003
    Event Type
    Other
    Date Received
    January 6, 2014
    Date of Event
    December 9, 2013
    Report Date
    December 9, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE AORTIC BODY DELIVERY SYSTEM COULD NOT BE ADVANCED THROUGH THE PT'S RIGHT SIDE POSSIBLY DUE TO KNOWN VESSEL CALCIFICATION AND TORTUOSITY. FOLLOWING WITHDRAWAL, A SMALL BEND WAS OBSERVED ON THE BATTERY SYSTEM. THE DELIVERY SYSTEM WAS THEN INSERTED INTO THE PT'S LEFT SIDE WITH THE OUTER SHEATH RETRACTED AND THE DELIVERY SYSTEM WITH THE UNCOVERED STENT GRAFT WAS ADVANCED TO THE ANEURYSM. UPON IMPLANTATION OF THE AORTIC BODY, THE CONTRALATERAL LEG OF THE GRAFT APPEARED COMPRESSED VIA ANGIOGRAPHIC IMAGING. THE PHYSICIAN ATTEMPTED A BRACHIAL APPROACH AND ADD'L WIRE SIZES TO CANNULATE THE CONTRALATERAL LEG, BUT WAS UNSUCCESSFUL. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE W/O IMPLANTATION OF THE ILIAC LIMB GRAFTS INTO THE AORTIC BODY. AS OF THIS REPORT, THE PT WAS REPORTED AS DOING FINE. IT IS NOT KNOWN IF A RE-INTERVENTION HAS BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8562 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS071013-10

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other