BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7341381 · Received March 15, 2018

    Report

    Report Number
    3001845648-2018-00123
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 12, 2018
    Report Date
    February 15, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163468 AND K113510. 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 EVO-25-30-8-C DEVICE OF LOT NUMBER C1354538 WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE PATIENT HAD THE FOLLOWING PRE-EXISTING CONDITION: REOCCURRENCE URETER TRANSITIONAL CELL CANCER. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE COOK REPRESENTATIVE: 1) WAS THE PATIENT ANATOMY TORTUROUS? YES, THE CURVES WHERE WITH SHARP ANGLES. 2) WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT AND INTRODUCER THROUGH THE OBSTRUCTED AREA? YES, IT WAS A VERY STIFF URETER TRANSITIONAL CELL CANCER. 3) WAS THE DIRECTIONAL BUTTON FULLY ENGAGED DURING DEPLOYMENT? YES. ENGINEERING INPUT WAS REQUESTED IN A WEEKLY MEETING TO REVIEW THE IMAGING AND INFORMATION PROVIDED AND DETERMINE A POTENTIAL ROOT CAUSE OF THIS EVENT. NO ADDITIONAL COMMENTS WERE MADE IN RELATION TO THE IMAGE RECEIVED. THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE THE TORTUROUS ANATOMY, CAUSING A BUILDUP OF PRESSURE AND RESULTING IN THE FLEXOR BREAKING. THIS WOULD ACCOUNT FOR THE PHYSICIANS INABILITY TO DEPLOY THE STENT AS REPORTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL EVO-25-30-8-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. A REVIEW OF THE QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THE LOT NUMBER C1354538. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C1354538. 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: THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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: ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED". THE STENOSIS WAS SEEN BY THE COLONOSCOPE, THAN GUIDE WIRE WAS DELIVERED THROUGH CANNULA AND COLONIC STENT WAS DELIVERED OVER THE GUIDE WIRE. WHILE DEPLOYING THE STENT THE TRIGGER SUDDENLY MADE A CRASH VOICE AND THE STENT COULD NOT BE DEPLOYED ANYMORE. THE STENT WAS REMOVED AND EXCHANGED BY ANOTHER SAME STENT. REPORTING BASED ON PRECEDENCE OF FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED" ISSUE FOR THIS DEVICE FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185167 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48028 10827002480282

    Patients

    Seq Age Sex Outcome Treatment
    1