BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4067579 · Received August 28, 2014

    Report

    Report Number
    3001845648-2014-00153
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 1, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K093619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT MEETS REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING CRITERIA ESTABLISHED FOR THIS PRODUCT FAMILY FOR 'STENT MIGRATION'. THERE WAS NO (B)(4) DEVICES OF LOT # C881261 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A POSSIBLE CAUSE OF STENT MIGRATION MAY BE THAT THE STENT WAS NOT PLACED SYSTEMICALLY WITH THE STRICTURE. THIS COULD LEAD TO MIGRATION AS THE STENT WOULD NOT HAVE AS MUCH ANCHORAGE AS IT WOULD HAVE HAD IF IT WAS PLACED SYMMETRICALLY WITH BOTH FLANGES EXTERNAL TO THE LESION. OTHER POTENTIAL CAUSES OF STENT MIGRATION ARE IF THE STENT WAS PLACED BEYOND THE STRICTURE OR IF AN INCORRECT SIZED STENT WAS SELECTED. AS PER THE "PRECAUTIONS" REFERENCED IN THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE, "A COMPLETE DIAGNOSTIC EVALUATION MUST BE PERFORMED PRIOR TO USE TO DETERMINE PROPER STENT SIZE." MIGRATION IS A KNOWN POTENTIAL COMPLICATION AS PER INSTRUCTION FOR USE. THE IFU ALSO ADVISES THE USER TO CONFIRM DESIRED STENT POSITION FLUOROSCOPICALLY PRIOR TO DEPLOYING THE STENT. THE INSTRUCTIONS FOR USE, IFU0061-4, ALSO INCLUDES INSTRUCTIONS ON REPOSITIONING THE STENT AFTER PLACEMENT. A REVIEW OF THE MANUFACTURING INSTRUCTIONS FOR (B)(4) DEVICE REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PRIOR TO DISTRIBUTION EVOLUTION DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. ANOTHER (B)(4) DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE STENT WAS PLACED IN THE DESIRED POSITION. THE SAFETY WIRE WAS PULLED OUT AFTER THE STENT WAS FULLY DEPLOYED, THE STENT MIGRATED UPWARDS FROM THE DESIGNATED POSITION. THE DOCTOR PLACED ANOTHER EVOLUTION STENT ON THE STRICTURE TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523749 EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C881261

    Patients

    Seq Age Sex Outcome Treatment
    1