BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 6302645 · Received February 3, 2017

    Report

    Report Number
    3008011247-2017-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 6, 2017
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB3480J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CLINICAL ASSESSMENT FOR THIS EVENT, THE MOST LIKELY CAUSE OF THE REPORTED DIFFICULT TO SEPARATE WAS DETERMINED TO BE UNKNOWN/UNDETERMINED DUE TO LACK OF RELEVANT MEDICAL INFORMATION. A CLINICAL ASSESSMENT SHOWED THAT THE DEVICE HAD AN UNKNOWN CONTRIBUTION TO THIS EVENT. PROCEDURE, ANATOMY, AND USER-RELATED ISSUES COULD NOT BE FOUND. THERE WERE NO OFF LABEL OR CAUTIONARY PRODUCT USE CONDITIONS THAT WERE FOUND. BASED ON THE CLINICAL ASSESSMENT THE MOST LIKELY CAUSE OF THE REPORTED LOSS OF SEAL WAS FOUND TO BE USER RELATED. THE TENSION ON THE AORTIC BODY DURING MANIPULATIONS TO DEMATE MAY HAVE UNINTENTIONALLY DISPLACED THE RINGS FROM THEIR INTENDED POSITION. ADDITIONALLY THE ELEVATED ANTICOAGULATION STATUS OF THE PATIENT LIKELY CONTRIBUTED TO THE EVENT. OFF LABEL OR CAUTIONARY PRODUCT USE CONDITIONS COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE QUALITY RECORDS SHOWS THAT THE DEVICE DEMONSTRATED COMPLIANCE TO ESTABLISHED PROCEDURES AND SPECIFICATIONS AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING THE PLACEMENT OF A BALLOON EXPANDABLE STENT. 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
    82799 OVATION IX ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-J FS120516-42 M701TVAB3480J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PALMAZ STENT