BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6943384 · Received October 12, 2017

    Report

    Report Number
    3001845648-2017-00452
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    August 11, 2017
    Report Date
    August 17, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # "K101530 AND K163468". COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE: "DURING AN EGD WITH DUODENAL STENT PLACEMENT THE EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED WAS USED. THE INNER CATHETER WOULD ADVANCE FORWARD BUT THE STENT WOULD NOT. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. " 1 X EVO-22-27-9-D OF LOT NUMBER C1351078 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED ON RETURN AND THE LOCKWIRE WAS STILL IN PLACE. AS ADDITIONAL INFORMATION WAS PROVIDED THAT THE STENT WAS NOT PARTIALLY DEPLOYED WHEN REMOVED FROM THE PATIENT IT IS ASSUMED THAT THE PARTIAL DEPLOYMENT OCCURRED OUTSIDE THE PATIENT. THERE WAS A KINK EVIDENT AT THE HANDLE OF THE FLEXOR WHICH COULD POSSIBLY HAVE OCCURRED ON TRANSPORT BACK. THE RED SHUTTLE DEPLOYMENT MARKER WAS TOWARDS THE MIDDLE OF THE HANDLE. THE DIRECTIONAL BUTTON WAS IN THE NEUTRAL POSITION ON RETURN OF THE DEVICE. ACTUATION OF THE DEVICE WAS POSSIBLE FOR DEPLOYMENT/RETRACTION. THE STENT WAS DEPLOYED DURING LAB EVALUATION THEREFORE THE KINK IN THE FLEXOR AT THE HANDLE HAD NO IMPACT ON DEPLOYMENT. THE FLEXOR WAS CUT AT THE HANDLE AND THERE WAS NO EVIDENCE OF STRETCHING OR ANY NOTABLE ISSUE OBSERVED. THE INNER CATHETER WAS REMOVED DURING LAB AND SHOWED NO DEFECTS. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. HOWEVER, USER ERROR IS SUSPECTED TO BE A CONTRIBUTORY FACTOR AS THE DIRECTIONAL BUTTON WAS SEEN TO BE IN THE NEUTRAL POSITION ON RETURN OF THE DEVICE AND AS THERE WAS NO ISSUES EXPERIENCED DEPLOYING THE STENT DURING LAB EVALUATION. PRODUCT MANAGER HAS BEEN CONTACTED TO REQUEST THAT TRAINING BE PROVIDED TO THE CUSTOMER. PRIOR TO DISTRIBUTION ALL EVO-22-27-9-D DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-22-27-9-D REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. AS PER THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED OF THE FOLLOWING: ¿TO RESUME DEPLOYMENT, PUSH BUTTON TO OPPOSITE SIDE AGAIN AND HOLD THUMB ON BUTTON FOR FIRST STROKE WHILE SQUEEZING TRIGGER". ON REVIEW OF THE INFORMATION PROVIDED AND FROM LAB EVALUATION OF THE DEVICE RETURNED, IT WOULD SUGGEST THAT THERE IS A POSSIBILITY THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION PROVIDED, THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE OF 'DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM' AS REPORTED TO CUSTOMER RELATIONS: " DURING AN EGD WITH DUODENAL STENT PLACEMENT THE EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED WAS USED. THE INNER CATHETER WOULD ADVANCE FORWARD BUT THE STENT WOULD NOT. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726167 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1