BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6721125 · Received July 18, 2017

    Report

    Report Number
    3001845648-2017-00279
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    May 16, 2017
    Report Date
    July 18, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GG
    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) # K101530 / K163468 1 X EVO-22-27-6-D OF LOT NUMBER C1207363 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE RED SHUTTLE DEPLOYMENT MARKER WAS AT THE BACK OF THE HANDLE PASSED THE POINT OF NO RETURN. THERE WAS NO STENT EXPOSURE FROM THE SHEATH ON RETURN AND THE LOCKWIRE WAS STILL IN PLACE. THE FLEXOR WAS NOTED TO HAVE STRETCHED AT THE HANDLE. THE HANDLE WAS OPENED DURING LAB EVALUATION TO SHOW THAT THE FLEXOR WAS BROKEN. THE STENT WAS MANUALLY DEPLOYED AND NOTED TO BE FINE. A DISC WITH IMAGES WAS RETURNED WITH THE DEVICE AND WAS REVIEWED DURING LAB EVALUATION. IMAGES SHOW DEPLOYMENT OF A STENT DURING THE PROCEDURE WHICH IS ASSUMED TO BE THE DEVICE THAT WAS USED TO FINISH THE PROCEDURE AS THE COMPLAINT DEVICE WAS RETURNED WITH THE STENT FULLY RETRACTED. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS BROKEN. AS USAGE CONDITION CANNOT BE REPLICATED WITHIN THE LABORATORY SETTING, A DEFINITIVE 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-22-27-6-D 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 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.

    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) # K101530 / K163468 THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THE STENT DID NOT EXPAND DURING THE MANIPULATION. STENT RELEASE PROCESS WAS FAILED.

    Description of Event or Problem · 0

    THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY. THE STENT DID NOT EXPAND DURING THE MANIPULATION. STENT RELEASE PROCESS WAS FAILED.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) # K101530 / K163468. THIS REPORT IS BEING SUBMITTED DUE TO CORRECTIONS: IT MAY BE NOTED THAT A PROJECT (B)(4) HAS BEEN ASSIGNED TO PRODUCT DEVELOPMENT TO FURTHER INVESTIGATE STENT DEPLOYMENT ISSUES OF THIS NATURE IN AN EFFORT TO ELIMINATE FUTURE OCCURRENCES.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED DUE CORRECTIONS THE STENT DID NOT EXPAND DURING THE MANIPULATION. STENT RELEASE PROCESS WAS FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502450 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48025 10827002480251

    Patients

    Seq Age Sex Outcome Treatment
    1