BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3852337 · Received June 5, 2014

    Report

    Report Number
    2031527-2014-00184
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    February 14, 2013
    Report Date
    March 3, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. THE PATIENT MEDICAL INFORMATION WAS REVIEWED BY CLINICAL COMPLAINT SPECIALIST WITH THE FOLLOWING INFORMATION: THE REPORTED EVENT WAS CONFIRMED, BUT THE ASSESSMENT SUGGESTS THAT THE KINK WAS PRESENT WHEN THE DEVICE WAS FIRST DEPLOYED. IT WAS NOT CONFIRMED IF THERE WAS FURTHER PROGRESSION OVER TIME DUE TO LACK OF CLINICAL INFORMATION. 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 THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED ISSUE WAS NOT IDENTIFIED. THE CLINICAL IMAGES SHOW THAT THE STENT APPEARS TO BE RESTRICTED FROM FULL EXPANSION, BUT IT COULD NOT BE DETERMINED IF THE CONDITION WAS RELATED TO ANATOMY OR TO DIFFICULTY WITH DEPLOYMENT. THERE WAS NO MENTION OF BALLOONING THE DEVICE, WHICH MAY HAVE HELPED EXPAND THE DEVICE AND REMOVE THE REPORTED KINK. THERE IS A POTENTIAL FOR THE EVENT TO HAVE BEEN DEVICE RELATED, BUT NO DEVICE ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 12 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AND A SUPRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY SCAN REVEALED A KINK ON THE MAIN BODY. THE PATIENT WILL BE BROUGHT BACK TO TREAT THE KINK ON (B)(6) 2014 WITH AN ADDITIONAL AORTIC EXTENSION. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329348 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-120/I16-40 1099450-002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR