BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 7884452 · Received September 18, 2018

    Report

    Report Number
    3001845648-2018-00430
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 20, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER: K121430. 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. DEVICE EVALUATION: THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1473295 WAS RETURNED TO COOK IRELAND AND EVALUATED ON THE 05-SEPT-2018. LAB EVALUATION: UPON EVALUATION OF THE RETURNED DEVICE, A MARK (DAMAGE) WAS SEEN ON THE YELLOW RADIOPAQUE MARKER. THERE WAS ALSO SLIGHT SEPARATION OF YELLOW RADIOPAQUE MARKER AND BLACK FILLER TUBING. THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. ROOT CAUSE: DAMAGE TO THE PROXIMAL END OF YELLOW RADIOPAQUE MARKER BELIEVED TO BE CAUSED BY THE GRASPING FEATURE/SUTURE GETTING CAUGHT ON THE YELLOW RADIOPAQUE MARKER WHICH WOULD SUPPORT THE COMPLAINT DESCRIPTION OF THE STENT BEING REMOVED WITH THE DEVICE. DOCUMENTS REVIEW: PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B 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. WORK INSTRUCTION INCLUDES FUNCTIONAL CHECK : ¿DEPLOY THE STENT APPROXIMATELY 50% AND RECAPTURE IT TO ENSURE IT FUNCTIONS CORRECTLY.¿ MANUFACTURING TEAM MEMBERS (MTM,S) ARE INSTRUCTED AS FOLLOWS: ¿INSPECT FOR VISUAL DEFECTS; I.E. LOOSE OR EMBEDDED FOREIGN MATERIALS, ROUGH OR SHARP EDGES, KINKS¿ ¿VISUAL INSPECTIONS OF PRODUCT AND PACKAGING¿ THE RELEVANT MTM IS INSTRUCTED TO CHECK FOR ¿VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS.¿ UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THE LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C1473295. 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: THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. 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 DEVICE WAS USED FOR STENT PLACEMENT ON A PATIENT WITH THE DISTAL BILE DUCT STENOSIS. THE STENT WAS CAUGHT ON THE INNER CATHETER AT THE END OF PHASE OF STENT DEPLOYMENT, WHICH PREVENTED FULL STENT DEPLOYMENT. THE PHYSICIAN PULLED THE WHOLE DELIVERY SYSTEM TO DEAL WITH THE EVENT, THEN THE STENT WAS PULLED TOGETHER WITH THE DELIVERY SYSTEM. AFTER REMOVING THE DEVICE WITH THE STENT, ANOTHER MANUFACTURER'S SIMILAR STENT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728248 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1473295 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1