BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 4090602 · Received September 15, 2014

    Report

    Report Number
    2031527-2014-00265
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. DEVICE REMAINS IMPLANTED IN PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. IMAGING STUDIES WERE PROVIDED AND REVIEWED BY INTERNAL MEDICAL DIRECTOR WITH THE FOLLOWING CONCLUSION: THE SUPPLIED IMAGING DOES NOT ALLOW US TO IDENTIFY AND/OR DIAGNOSE TYPE II VERSUS TYPE III (A OR B) ENDOLEAK; THE CONTRAST SEEN IN THE IMAGES COULD BE FROM ANY OF THESE SOURCES. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT ALL UNITS WERE CONSUMED AND 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 31 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED AN ENDOLEAK BELIEVED TO BE A POSSIBLE FABRIC TEAR. THE PHYSICIAN IS DETERMINING COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570404 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-60/I16-40 W11-3693-015

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR