BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6916649 · Received October 5, 2017

    Report

    Report Number
    3001845648-2017-00431
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    August 18, 2017
    Report Date
    August 23, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480282
    PMA / PMN Number
    K113510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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. THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE: ¿DEVICE FAILED TO DEPLOY. "AS PER COMPLAINT FORM": WHEN THE DR HAD THE STENT IN POSITION HE TRIED TO DEPLOY IT AND IT WOULD NOT OPEN¿ 1 X EVO-25-30-8-C WAS RETURNED TO CIRL FOR EVALUATION. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE LOCKWIRE WAS IN PLACE ON RETURN AND THERE WAS NO STENT EXPOSURE FROM THE SHEATH. THE RED SHUTTLE DEPLOYMENT MARKER WAS SEEN TO BE TOWARDS THE FRONT OF THE HANDLE. ACTUATION FOR DEPLOYMENT OR RETRACTION WAS NOT POSSIBLE. THE HANDLE OF THE DEVICE 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 SEEN TO BE BROKEN AT THE SHUTTLE CAP DURING LAB EVALUATION. 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. A REVIEW OF THE QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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. ¿FQC INSTRUCTION FOR DUODENAL/COLONIC STENT INTRODUCER AND HANDLE IRS,¿ THE RELEVANT MTM IS INSTRUCTED TO DO THE FOLLOWING: ¿INSPECT FOR VISUAL DEFECTS; I.E. LOOSE OR EMBEDDED FOREIGN MATERIALS, KINKS, ROUGH OR SHARP EDGES. THE RELEVANT MTM IS INSTRUCTED OF THE FOLLOWING: ¿DEPLOY THE STENT APPROXIMATELY 50% AND INSPECT.¿ ¿VISUAL INSPECTIONS OF PRODUCT AND PACKAGING¿ THE RELEVANT MTM IS INSTRUCTED TO CHECK FOR ¿VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS.¿ A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVOLUTION DEVICE REVEALED NO DISCREPANCIES IN THE MANUFACTURING RECORDS THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT. 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 VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR 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

    INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE OF 'FLEXOR KINKED/ STRETCHED/ BROKE/ COMPRESSED' DEVICE FAILED TO DEPLOY. "AS PER COMPLAINT FORM": WHEN THE DR HAD THE STENT IN POSITION HE TRIED TO DEPLOY IT AND IT WOULD NOT OPEN.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K163468. (B)(4). EXEMPTION NUMBER: E2016031. I(B)(4). 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 TO CORRECTIONS INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE OF 'FLEXOR KINKED/ STRETCHED/ BROKE/ COMPRESSED'. DEVICE FAILED TO DEPLOY. "AS PER COMPLAINT FORM": WHEN THE DR HAD THE STENT IN POSITION HE TRIED TO DEPLOY IT AND IT WOULD NOT OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695838 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48028 10827002480282

    Patients

    Seq Age Sex Outcome Treatment
    1