BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 2739490 · Received September 11, 2012

    Report

    Report Number
    2031527-2012-00132
    Event Type
    Malfunction
    Date Received
    September 11, 2012
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE REVIEW OF LOT RECORDS/WORK ORDERS AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. A REVIEW OF PRIOR REPORTED EVENTS INDICATES THAT THE GUIDEWIRE MAY HAVE BEEN LOST AND/OR FLUOROSCOPY MAY NOT HAVE BEEN USED APPROPRIATELY, AS IDENTIFIED IN THE IFU. THE IFU ALSO INDICATES UNDER CAUTION, WHILE IMPLANTING THE STENT GRAFT AS USE OF FLUOROSCOPY TO ENSURE THE IMPLANTED STENT GRAFT IS NOT INADVERTENTLY MOVED AND TO MAINTAIN GUIDEWIRE POSITION DURING THE DELIVERY SYSTEM INSERTION. IT IS LIKELY THAT ACCESS TO GUIDEWIRE WAS LOST AND FLUOROSCOPY WAS NOT USED APPROPRIATELY DURING THE PROCEDURE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ENDOVASCULAR REPAIR OF A PROXIMAL TYPE 1 ENDOLEAK (REFERENCE MANUFACTURER REPORT NUMBER 2031527-2012-00124) A INFRARENAL AORTIC EXTENSION WAS INADVERTENTLY DEPLOYED BEHIND THE STENT STRUT OF THE BIFURCATED DEVICE. THE PHYSICIAN PLACED A BALLOON EXPANDABLE STENT, WHICH FREED THE EXTENSION FROM THE MAIN BODY CREATING A NORMAL LUMEN. THE ENDOLEAK WAS RESOLVED AND NO VISUAL DISRUPTION OF THE BIFURCATED STENT REMAINED AT THE CONCLUSION OF PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A28-28/C75 W11-3116R-011

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR