BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3813061 · Received May 15, 2014

    Report

    Report Number
    3008011247-2014-00027
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE PATIENT RETURNED FOR A FOLLOW-UP ON AN UNKNOWN DATE AND PRESENTED WITH A POTENTIAL TYPE IA AND/OR TYPE II ENDOLEAK; THE TYPE OF ENDOLEAK COULD NOT BE CONFIRMED BY THE IMPLANT SITE AND IMAGING WAS NOT PROVIDED TO TRIVASCULAR FOR ANALYSIS. TRIVASCULAR WAS NOTIFIED ON (B)(6) 2014 THAT THE PATIENT WAS CONVERTED TO OPEN SURGERY ON (B)(6) 2014 AND THE ENDOLEAK WAS CONFIRMED AS A TYPE II. TYPE II ENDOLEAKS ARE NOT CONSIDERED TO BE DEVICE RELATED BUT ANATOMY RELATED. THE PATIENT IS REPORTED AS DOING WELL AFTER THE CONVERSION AND THERE HAVE BEEN NO ADDITIONAL ADVERSE SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291246 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS021513-06

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention