BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4907518 · Received July 10, 2015

    Report

    Report Number
    3008011247-2015-00066
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    May 26, 2015
    Report Date
    June 11, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 MONTH POST-OPERATIVE CT IMAGING SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK DUE TO THE AORTIC BODY STENT GRAFT BEING POSITIONED BELOW THE INTENDED LANDING ZONE, PLACING THE SEALING RINGS WITHIN AN AORTIC VESSEL DIAMETER OUTSIDE THE TREATMENT RANGE FOR THE IMPLANTED STENT GRAFT. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2015 TO PLACE AN AORTIC CUFF SUCCESSFULLY RESOLVING THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451121 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS102914-09

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention GORE AORTIC CUFF (45MM)| PALMAZ STENT