BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 3202148 · Received June 28, 2013

    Report

    Report Number
    3001845648-2013-00060
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    March 27, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K080359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVO-20-25-15-E DEVICE OF LOT C857128 IN STOCK AT THE TIME OF THE INVESTIGATION. THE 1 X EVO-20-25-15-E DEVICE OF LOT C857128 WAS RETURNED FOR EVALUATION. IT WAS RETURNED IN ITS ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STENT RETURNED FULLY DEPLOYED AND RELEASED FROM THE DELIVERY SYSTEM. THE LOCK WIRE WAS NOT RETURNED WITH THE DEVICE WHICH INDICATED THAT THE USER DIDN'T HAVE DIFFICULTY IN REMOVING IT FROM THE DELIVERY SYSTEM TO RELEASE THE STENT. THE RETURNED WITH THE DEVICE WHICH INDICATED THAT THE USER DIDN'T HAVE DIFFICULTY IN REMOVING IT FROM THE DELIVERY SYSTEM TO RELEASE THE STENT. THE RETURNED FULLY DEPLOYED STENT DID NOT APPEAR TO BE DAMAGED. THERE WAS NO CROWN OR SUTURE DAMAGE NOTED. THE INNER PEEK WAS NOTED TO BE BENT DISTAL OF THE BILUMEN TUBE, HOWEVER, THIS WOULD NOT HAVE CONTRIBUTED TO THE DIFFICULTY THAT THE USER HAD IN ATTEMPTING TO DEPLOY TO THE STENT. THIS BEND MAY POSSIBLY HAVE OCCURRED DURING HANDLING OR USE, HOWEVER THIS CANNOT BE CONFIRMED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AS THE STENT RETURNED FULLY DEPLOYED AND RELEASED FROM THE DELIVERY SYSTEM. THERE WAS NO STENT DAMAGE EVIDENT. AS ACTUAL USE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THIS COMPLAINT. PRIOR TO DISTRIBUTION EVOLUTION DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-20-25-15-E OF LOT C857128 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AS PER THE INSTRUCTIONS FOR USE, IFU WARNING SECTION ADVISES THE USER OF THE FOLLOWING: "THE STENT IS NOT INTENDED TO BE REMOVED AND IS CONSIDERED A PERMANENT IMPLANT. ATTEMPTS TO REMOVE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO ESOPHAGEAL MUCOSA." A TWO YEAR REVIEW OF THE COMPLAINTS HISTORY FOR EVO-20-25-15-E DEVICES REVEALED NO OTHER COMPLAINTS OF THIS NATURE "STENT STUCK DURING DEPLOYMENT" FOR THIS RPN. THIS THEREFORE REPRESENTS AN ISOLATED OCCURRENCE FOR THIS RPN OVER THIS TIME FRAME. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THERE WERE NO ADVERSE EFFECTS TO THE PT. THIS COMPLAINT IS BEING REPORTED AS THE STENT IS NOT INTENDED TO BE REMOVED AS IT IS CONSIDERED A PERMANENT IMPLANT AND THERE IS POTENTIAL THAT ON REMOVAL OF A STENT, DAMAGE CAN BE CAUSED TO THE ESOPHAGEAL MUCOSA. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    "ACCORDING TO MY DISCUSSION WITH THE DOCTOR ABOUT THIS ISSUE, HE SAID THAT WHEN HE WAS SURE THAT THE STENT IS IN THE RIGHT POSITION AS NEEDED UNDER FLUOROSCOPY AND HE DECIDED TO DEPLOY IT. HE CONTINUED SQUEEZING THE GUN TILL THE STENT IS EXPOSED COMPLETELY AND HE WENT AFTER THE POINT OF NO RETURN THEN HE REMOVED THE SAFETY WIRE FROM THE BACK OF THE DEVICE AND WHEN HE WAS PULLING BACK THE DEVICE, THE STENT WAS ATTACHED TO THE DEVICE AND CAME OUT FROM THE PT'S MOUTH WITH THE DEVICE, SO THE PROCEDURE FAILED." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295209 EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C857128

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR