BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 5088800 · Received September 18, 2015

    Report

    Report Number
    3008011247-2015-00106
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 19, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE POST-OPERATIVE, THERE WAS NO EVIDENCE OF A TYPE IB ENDOLEAK. TYPE II ENDOLEAKS WERE NOTED AT FROM MULTIPLE PATENT LUMBAR VESSELS (RO+43, RO+86, RO+130); TWO OF WHICH WERE NEAR THE JUNCTURE OF THE AORTIC BODY/ ILIAC LIMBS WHICH MAY HAVE BEEN MISTAKEN FOR A TYPE IB ENDOLEAK. TYPE II ENDOLEAKS ARE NOT CONSIDERED TO BE RELATED TO THE DEVICE BUT RATHER RELATED TO THE ANATOMY.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 YEAR FOLOW-UP CT SHOWED THE PRESENCE OF A TYPE IB ENDOLEAK. A RE-INTERVENTION WAS PERFORMED TO PLACE AN ILIAC LIMB EXTENSION TO EXTEND THE SEAL AND THE ENDOLEAK WAS SUCCESSFULLY EXCLUDED. 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
    618205 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-IL1422140-E FS012514-01

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Required Intervention