BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6740026 · Received July 25, 2017

    Report

    Report Number
    3001845648-2017-00303
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    June 15, 2017
    Report Date
    June 27, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. PMA/510(K) #K113510 / K163468. 1X EVO-25-30-8-C OF LOT NUMBER C1356176 WAS RETURNED TO CIRL FOR EVALUATION. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STENT WAS FULLY RETRACTED INTO THE SHEATH ON RETURN. THE RED SHUTTLE DEPLOYMENT MARKER WAS TOWARDS THE BACK HALF OF THE HANDLE AND THE LOCKWIRE WAS IN PLACE ON RETURN. DEPLOYMENT AND RETRACTION WERE NOT POSSIBLE. THE HANDLE WAS DISMANTLED DURING LAB EVALUATION TO SHOW THAT THE FLEXOR HAD BROKEN AT THE SHUTTLE CAP. THE STENT WAS MANUALLY DEPLOYED AND WAS NOTED TO BE FINE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS BROKEN AT THE SHUTTLE CAP. A POSSIBLE CAUSE FOR THE ISSUE OCCURRING MAY BE DUE TO DELAMINATION OF THE PTFE LINER OF THE OUTER SHEATH. AS USAGE CONDITION CANNOT BE REPLICATED WITHIN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. PRIOR TO DISTRIBUTION ALL EVO-25-30-8-C DEVICES ARE SUBJECTED TO 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 THIS EVOLUTION DEVICE OF LOT C1356176 REVEALED NO DISCREPANCIES IN THE MANUFACTURING RECORDS THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    IMPOSSIBLE TO RELEASE THE STENT AFTER OPENING 3/4 OF THE STENT. THE STENT STARTED TO RELEASE THEN AT HALF DEPLOYMENT THE STENT COULD NOT RELEASE MORE. SEEMED LIKE BROKEN IN THE SYSTEM. DOCTOR HAD TO REMOVE THE WHOLE SYSTEM WITH THE STENT AND USE ANOTHER DEVICE. NO ISSUE ON PATIENT.

    Additional Manufacturer Narrative · 1

    COOK (B)(4) LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) #K113510 / K163468. THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO CORRECTIONS. 1 X EVO-25-30-8-C OF LOT NUMBER C1356176 WAS RETURNED TO COOK (B)(4) FOR EVALUATION. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STENT WAS FULLY RETRACTED INTO THE SHEATH ON RETURN. THE RED SHUTTLE DEPLOYMENT MARKER WAS TOWARDS THE BACK HALF OF THE HANDLE AND THE LOCKWIRE WAS IN PLACE ON RETURN. DEPLOYMENT AND RETRACTION WERE NOT POSSIBLE. THE HANDLE WAS DISMANTLED DURING LAB EVALUATION TO SHOW THAT THE FLEXOR HAD BROKEN AT THE SHUTTLE CAP. THE STENT WAS MANUALLY DEPLOYED AND WAS NOTED TO BE FINE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS BROKEN AT THE SHUTTLE CAP. AS USAGE CONDITION CANNOT BE REPLICATED WITHIN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. A POSSIBLE CAUSE FOR THE ISSUE OCCURRING MAY BE DUE TO DELAMINATION OF THE PTFE LINER OF THE OUTER SHEATH PRIOR TO DISTRIBUTION ALL EVO-25-30-8-C DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT COOK (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVOLUTION DEVICE OF LOT C1356176 REVEALED NO DISCREPANCIES IN THE MANUFACTURING RECORDS THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. IT MAY BE NOTED THAT A PROJECT (B)(4) WAS ASSIGNED AT THIS TIME TO PRODUCT DEVELOPMENT TO FURTHER INVESTIGATE STENT DEPLOYMENT ISSUES OF THIS NATURE IN AN EFFORT TO ELIMINATE FUTURE OCCURRENCES. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1356176; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1356176. THE INSTRUCTIONS FOR USE, IFU0052-10 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. QUALITY ENGINEERING ASSESSED THE COMPLAINT AS PER (B)(4) AND THE RISK HAS BEEN DETERMINED TO BE MODERATE. NO IMMEDIATE ACTION IS REQUIRED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO CORRECTIONS (RISK ASSESSMENT OMITTED). IMPOSSIBLE TO RELEASE THE STENT AFTER OPENING 3/4 OF THE STENT. THE STENT STARTED TO RELEASE THEN AT HALF DEPLOYMENT THE STENT COULD NOT RELEASE MORE. SEEMED LIKE BROKEN IN THE SYSTEM. DOCTOR HAD TO REMOVE THE WHOLE SYSTEM WITH THE STENT AND USE ANOTHER DEVICE. NO ISSUE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519785 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48028 10827002480282

    Patients

    Seq Age Sex Outcome Treatment
    1