BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 6309439 · Received February 7, 2017

    Report

    Report Number
    3008011247-2017-00011
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 11, 2017
    Report Date
    January 11, 2017
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2080J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICAL ASSESSMENT COULD NOT BE COMPLETED DUE TO LACK OF MEDICAL RECORDS AND IMAGING. BASED ON THE REPORTED EVENT, THE MOST LIKELY CAUSE OF THE REPORTED LIMB OCCLUSION WAS DETERMINED TO BE ANATOMY RELATED. A CLINICAL ASSESSMENT SHOWED THAT THE DEVICE DID NOT LIKELY CONTRIBUTE TO THE EVENT. PROCEDURE-RELATED CIRCUMSTANCES ARE NOT LIKELY TO HAVE CONTRIBUTED TO THIS EVENT. ANATOMICAL FACTORS SUCH AS SMALL DIAMETER VESSEL AT THE LANDING ZONE AND CONSIDERABLE CIRCUMFERENTIAL CALCIFICATION IN THE ILIAC ARTERY LIKELY CONTRIBUTED TO THE EVENT. 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

    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 POTENTIAL TYPE IA ENDOLEAK IN THE PRESENCE OF SIGNIFICANT CALCIUM WITHIN THE AORTA THAT COULD NOT BE RESOLVED FOLLOWING BALLOONING AND 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
    89936 OVATION IX ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2080-J FS051316-01 M701TVAB2080J1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other PALMAZ STENT