BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4889348 · Received July 2, 2015

    Report

    Report Number
    3008011247-2015-00059
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    BASED ON A FOLLOW-UP COMMUNICATION RECEIVED FROM THE PHYSICIAN, THE PATIENT RETURNED FOR FOLLOW-UP AND SHOWED NO PRESENCE OF AN ENDOLEAK AND RESOLVED WITHOUT RE-INTERVENTION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC BODY STENT GRAFT REPORTEDLY DISPLACED DISTAL TO THE INTENDED LANDING ZONE IN A LOCATION OUTSIDE THE AORTIC DIAMETER TREATMENT RANGE FOR THE DEVICE. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING BALLOONING AND THE PLACEMENT OF AN AORTIC CUFF. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430090 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-E FS020415-29

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other