BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6776721 · Received August 9, 2017

    Report

    Report Number
    3001845648-2017-00321
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    June 23, 2017
    Report Date
    July 12, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ¿THE STENT COULD NOT DEPLOY FROM THE DELIVERY SYSTEM, THAT THE STENT COULD NOT BE DEPLOYED.¿ 1 X EVO-22-27-9-D WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE LOCKWIRE WAS IN PLACE AND THERE WAS NO STENT EXPOSURE. THE RED SHUTTLE DEPLOYMENT MARKER WAS TOWARDS THE BACK HALF OF THE HANDLE ON RETURN. ON ATTEMPTING TO ACTUATE THE HANDLE, DEPLOYMENT OR 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 NOTED TO BE FINE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS BROKEN AT THE SHUTTLE CAP. AS USAGE CONDITIONS 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-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. AS PER THE INSTRUCTIONS FOR USE NOTES SECTION THE USER IS INSTRUCTED OF THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY 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

    THE STENT DID NOT OPEN. PATIENT INJURY AND RETURN TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # "K101530 AND K163468". COOK (B)(4) LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO CORRECTIONS. 1 X EVO-22-27-9-D OF LOT NUMBER C1347247 WAS RETURNED TO COOK (B)(4) FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE LOCKWIRE WAS IN PLACE AND THERE WAS NO STENT EXPOSURE. THE RED SHUTTLE DEPLOYMENT MARKER WAS TOWARDS THE BACK HALF OF THE HANDLE ON RETURN. ON ATTEMPTING TO ACTUATE THE HANDLE, DEPLOYMENT OR 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 NOTED TO BE FINE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS BROKEN AT THE SHUTTLE CAP. AS USAGE CONDITIONS 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-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 COOK (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVO-22-27-9-D DEVICE OF LOT C1347247 REVEALED NO DISCREPANCIES 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 # C1347247; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1347247. AS PER THE INSTRUCTIONS FOR USE, IFU0053-8, NOTES SECTION THE USER IS INSTRUCTED OF THE FOLLOWING: VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY 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 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). THE STENT DID NOT OPEN. PATIENT INJURY AND RETURN TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560655 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1