BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4375930 · Received December 31, 2014

    Report

    Report Number
    3008011247-2014-00100
    Event Type
    Injury
    Date Received
    December 31, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 4, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 54 DAY POST-OPERATIVE CT IMAGES SHOW THE PRESENCE OF A TYPE IA ENDOLEAK. A REVIEW OF THE IMAGING INDICATES THAT THE AORTIC BODY STENT GRAFT WAS IMPLANTED LOWER THAN THE INTENDED LANDING ZONE, PLACING THE SEALING RINGS IN A VESSEL DIAMETER OUTSIDE THE TREATMENT RANGE FOR THE DEVICE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND NO PLANNED REINTERVENTION. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861243 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-E FS050914-49

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other