BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3101018 · Received May 8, 2013

    Report

    Report Number
    2031527-2013-00112
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT HENCE DEVICE EVALUATION COULD NOT BE PERFORMED. THE CAUSE OF THE SEPARATION OF THE LEFT COMMON ILIAC LIMB EXTENSION GRAFT AND THE LEFT EXTERNAL ILIAC LIMB EXTENSION GRAFT MAY BE ATTRIBUTED TO POOR GRAFT APPOSITION OF THE LEFT ILIAC LIMB EXTENSION GRAFTS, INCLUDING THE COMPETITOR'S GRAFT IN THE LEFT INTERNAL ILIAC ARTERY TO THE VESSEL WALLS. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENTS. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.UPDATED CONTACT DETAILS.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4): REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION, A LIMB EXTENSION AND COMPETITOR'S STENT GRAFT IN THE LEFT HYPOGASTRIC ARTERY (HYPO SNORKEL METHOD), A FOLLOW UP COMPUTED TOMOGRAPHY SCAN REVEALED A DISCONNECT BETWEEN THE LEFT LIMB OF THE BIFURCATED DEVICE AND THE LIMB EXTENSION, AND THE MIGRATION OF THE COMPETITOR'S STENT GRAFT. THE PATIENT WAS TREATED WITH ADDITIONAL LIMB EXTENSION, TO BRIDGE BETWEEN THE SEPARATED COMPONENTS. AN ATTEMPT WAS MADE TO CANNULATE THE COMPETITOR'S STENT GRAFT BY BILATERALLY IMPLANTING ADDITIONAL LIMB EXTENSIONS BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO IMPLANT AORTO-UNI-ILIAC AND FEMORAL TO FEMORAL BYPASS PROCEDURE. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201768 AFX SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. I16-16/C88 SA 1039872-008

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention