BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3982191 · Received August 5, 2014

    Report

    Report Number
    3008011247-2014-00058
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 2, 2014
    Report Date
    September 25, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP COMMUNICATION RECEIVED FROM THE PHYSICIAN STATED THAT THE ENDOLEAK RESOLVED WITHOUT RE-INTERVENTION FOUR WEEKS FOLLOWING THE IMPLANT PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL SEQUELAE REPORTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. IT WAS REPORTED THAT THE QUALITY OF THE IMAGING EQUIPMENT WAS POOR AND THAT THE PATIENT, WHO WAS UNDER LOCAL SEDATION, MOVED THROUGHOUT THE IMPLANT PROCEDURE. BOTH FACTORS LED TO DIFFICULTIES IN ACCURATELY POSITIONING THE AORTIC BODY STENT GRAFT PRIOR TO COMPLETE STENT DEPLOYMENT. THE AORTIC BODY STENT GRAFT WAS FILLED WITH POLYMER AND THE ILIAC LIMB STENT GRAFTS WERE DEPLOYED AS EXPECTED. A REVIEW OF THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK WHICH COULD NOT BE RESOLVED WITH THE USE OF A ANGIOGRAPHY BALLOON. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT UNTIL THE 1-MONTH FOLLOW-UP. THE INTRAOPERTIVE ANGIOGRAM WAS REVIEWED BY TRIVASCULAR ON (B)(6), 2014 CONFIRMING THE PRESENCE OF A TYPE IA ENDOLEAK. AS OF THE DATE OF THIS REPORT THE PATIENT HAS NOT RETURNED FOR A FOLLOW-UP, AND THERE HAVE BEEN NO PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456884 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-D FS021814-17

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other