BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6721094 · Received July 18, 2017

    Report

    Report Number
    3001845648-2017-00277
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 14, 2017
    Report Date
    July 18, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    PMA / PMN Number
    K101530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    )B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) #K101530 / K163468. THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO CORRECTIONS IT MAY BE NOTED THAT A PROJECT IRE0045-K HAS BEEN ASSIGNED TO PRODUCT DEVELOPMENT TO FURTHER INVESTIGATE STENT DEPLOYMENT ISSUES OF THIS NATURE IN AN EFFORT TO ELIMINATE FUTURE OCCURRENCES.

    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 FOLLOWING ADDITIONAL INFORMATION WAS ALSO PROVIDED: "THE STENT WAS PARTIALLY DEPLOYED WHEN REMOVED FROM THE PATIENT. THE RED MARKER ON THE TOP OF THE HANDLE WAS FAR BEHIND THE POINT OF NO RETURN AS WELL." 1 X EVO-22-27-9-D WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STENT WAS PARTIALLY EXPOSED FROM THE SHEATH ON RETURN. NO LOCKWIRE WAS IN PLACE ON RETURN AND THE RED SHUTTLE DEPLOYMENT MARKER WAS AT THE BACK OF THE HANDLE. IT WAS ATTEMPTED TO ACTUATE THE TRIGGER BUT DEPLOYMENT OR RETRACTION WAS 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.

    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 DUE TO CORRECTIONS. THE STENT COULD ONLY BE EXPOSED TEMPORARILY. SCOPE WAS IN A NORMAL POSITION; PHYSICIAN WAS NOT ABLE TO RELEASE THE EVO-22-27-9-D COMPLETELY. AFTER HE REMOVED THE EVO-22-27-9-D HE USED A HANARO STENT WITHOUT A PROBLEM.

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS THE STENT COULD ONLY BE EXPOSED TEMPORARILY. SCOPE WAS IN A NORMAL POSITION; PHYSICIAN WAS NOT ABLE TO RELEASE THE EVO-22-27-9-D COMPLETELY. AFTER HE REMOVED THE EVO-22-27-9-D HE USED A HANARO STENT WITHOUT A PROBLEM

    Description of Event or Problem · 0

    THE STENT COULD ONLY BE EXPOSED TEMPORARILY. SCOPE WAS IN A NORMAL POSITION; PHYSICIAN WAS NOT ABLE TO RELEASE THE EVO-22-27-9-D COMPLETELY. AFTER HE REMOVED THE EVO-22-27-9-D HE USED A HANARO STENT WITHOUT A PROBLEM

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) #K101530 / K163468. THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO CORRECTIONS. 1 X EVO-22-27-9-D WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STENT WAS PARTIALLY EXPOSED FROM THE SHEATH ON RETURN. NO LOCKWIRE WAS IN PLACE ON RETURN AND THE RED SHUTTLE DEPLOYMENT MARKER WAS AT THE BACK OF THE HANDLE. IT WAS ATTEMPTED TO ACTUATE THE TRIGGER BUT DEPLOYMENT OR RETRACTION WAS 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. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVO-22-27-9-D DEVICE OF LOT C1328254 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1328254; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS OCCURRED PREVIOUSLY WITH THIS LOT # C1328254 ((B)(4)). 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 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). THE STENT COULD ONLY BE EXPOSED TEMPORARILY. SCOPE WAS IN A NORMAL POSITION; PHYSICIAN WAS NOT ABLE TO RELEASE THE EVO-22-27-9-D COMPLETELY. AFTER HE REMOVED THE EVO-22-27-9-D HE USED A HANARO STENT WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502097 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1