BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3221748 · Received July 11, 2013

    Report

    Report Number
    2031527-2013-00155
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND IMAGING WERE PROVIDED AND REVIEWED BY A CLINICAL REPRESENTATIVE. THE REVIEW INDICATES A POSSIBLE TYPE II ENDOLEAK AND POSSIBLY A DISTAL ENDOLEAK, VERSUS THE REPORTED ENDOLEAK BETWEEN THE BIFURCATED DEVICE AND THE COMPETITOR LIMB EXTENSION. THEREFORE, THE LOCATION OF REPORTED ENDOLEAK BETWEEN THE DEVICES COULD NOT BE CONFIRMED, AND NEITHER THE CAUSE WAS DETERMINED. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, TWO INFRARENAL AORTIC EXTENSIONS AND ONE LIMB EXTENSION A COMPUTED TOMOGRAPHY SCAN IDENTIFIED A POSSIBLE TYPE III ENDOLEAK BETWEEN THE BIFURCATED DEVICE AND COMPETITORS CUFFS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. THE PATIENT WAS TREATED WITH AN ADDITIONAL BIFURCATED DEVICE AND TWO INFRARENAL AORTIC EXTENSIONS WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320762 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-90/I16-30 1045628-012

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention