BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3593239 · Received January 15, 2014

    Report

    Report Number
    3008011247-2014-00006
    Event Type
    Other
    Date Received
    January 15, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 20, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 SUBJECT RETURNED FOR THE ROUTINE 1 MONTH FOLLOW-UP AND UPON VIEWING THE CT IMAGING, ONE OF THE ILIAC LIMBS APPEARS DISCONNECTED PROXIMALLY FROM THE AORTIC BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41281 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-D FS061013-18

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other