BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7776038 · Received August 13, 2018

    Report

    Report Number
    3001845648-2018-00377
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 2, 2018
    Report Date
    August 13, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # : 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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: 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)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE EVO-25-30-10-C DEVICE OF LOT NUMBER C1421892 WAS RETURNED TO COOK IRELAND AND EVALUATED ON THE 25-JULY-2018. LAB EVALUATION: UPON EVALUATION OF THE RETURNED DEVICE, BREAKAGE WAS CONFIRMED IN THE OUTER SHELL OF THE HANDLE. LOCK WIRE WAS NOT RETURNED. DEPLOYMENT WAS POSSIBLE BUT RETRACTION WAS NOT POSSIBLE. THE BREAKAGE IN THE HANDLE IS NOT BELIEVED TO HAVE CONTRIBUTED TO THE COMPLAINT AS THE CUSTOMER WAS ABLE TO DEPLOY AND RECAPTURE THE STENT. ENGINEERING HAVE REVIEWED THE PHOTOS OF THE PRODUCT SENT BY THE CUSTOMER AND HAVE COMMENTED THAT NO LOCK WIRE CAN BE SEEN IN PHOTOS RECEIVED, THEREFORE IT MAY BE POSSIBLE THAT THE LOCK WIRE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO ISSUE IN THE LAB EVALUATION WITH THE AREA IN WHICH THE PHYSICIAN IS POINTING TO IN PHOTO". THE PHYSICIAN MAY BE POINTING TO THIS AREA AS THEY MAY BELIEVE THIS IS THE AREA THEY HAD THE PROBLEM WITH BUT THERE IS NO EVIDENCE FROM THE LAB EVALUATION TO CONFIRM THERE WAS A PROBLEM WITH THIS AREA. THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. ROOT CAUSE: THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. DOCUMENTS REVIEW: PRIOR TO DISTRIBUTION ALL EVO-25-30-10-C 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. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THE LOT NUMBER C1421892. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C1421892. IFU REVIEW: AS PER 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". ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. 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

    REPORT IS BEING SUBMITTED UNDER THE PRECEDENCE FOR "STENT REMOVED WHILE PARTIALLY EXPOSED". USER ADVANCED THE DELIVERY SYSTEM TO DESIRED POSITION AND FOLLOW THE STANDARD PROCEDURE TO RELEASE THE STENT SUCCESSFULLY. USER CONFIRMED THE STENT POSITION BEFORE RETRACT THE DELIVERY SYSTEM. THE STENT WAS RETRACTED ALONG WITH THE DELIVERY SYSTEM TOGETHER. USER USED ANOTHER SAME PRODUCT TO FINISH THE PROCEDURE.

    Description of Event or Problem · 0

    THE USER ADVANCED THE DELIVERY SYSTEM TO DESIRED POSITION AND FOLLOW THE STANDARD PROCEDURE TO RELEASE THE STENT SUCCESSFULLY. USER CONFIRMED THE STENT POSITION BEFORE RETRACT THE DELIVERY SYSTEM. THE STENT WAS RETRACTED ALONG WITH THE DELIVERY SYSTEM TOGETHER. SEE ATTACHED PICTURES. USER USED ANOTHER SAME PRODUCT TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617551 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48038 C1421892 10827002480381

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR