BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7809001 · Received August 23, 2018

    Report

    Report Number
    3001845648-2018-00392
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 25, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231297
    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-10-11-8-BDEVICE OF LOT NUMBER C1379270 WAS RETURNED TO CIRL AND EVALUATED ON THE 25-JULY-2018. LAB EVALUATION: UPON REVIEW OF THE RETURNED DEVICE, INKING WAS IDENTIFIED ON PROXIMAL FLEXOR. STENT WOULD NOT DEPLOY AND RESISTANCE WAS FELT. DIRECTIONAL BUTTON NOTED TO BE STIFF. STENT WOULD NOT DEPLOY AND RESISTANCE WAS FELT. VISUAL INSPECTION WAS THE METHOD BY WHICH THE DEFECT WAS DETERMINED. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ROOT CAUSE: BASED ON THE INFORMATION PROVIDED THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS THAT A KINK MAY HAVE OCCURRED AT SOME STAGE DURING THE PROCEDURE DUE TO TORTUOUS ANATOMY AND SEVERE STENOSIS AND THIS CAUSED A BUILD-UP OF PRESSURE RESULTING IN THE STENT DEPLOYMENT DIFFICULTIES EXPERIENCED BY THE USER. COMPLAINT PROBLEM STATEMENT "THE STENOSIS OF THE TARGET SITE WAS VERY SEVERE AND RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT AND INTRODUCER THROUGH THE OBSTRUCTED AREA. THEN HE ATTEMPTED TO PULL THE TRIGGER TO START STENT DEPLOYMENT, BUT HE COULD NOT PULL THE TRIGGER AT ALL." DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL EVO-10-11-8-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. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-10-11-8-B DEVICE OF LOT NUMBER C1379270 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ¿VISUAL INSPECTIONS OF PRODUCT AND PACKAGING¿ THE RELEVANT MTM IS INSTRUCTED TO CHECK FOR ¿VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS.¿ THE RELEVANT MTMS ARE INSTRUCTED AS FOLLOWS: ¿INSPECT FOR VISUAL DEFECTS; I.E. LOOSE OR EMBEDDED FOREIGN MATERIALS, KINKS, ROUGH OR SHARP EDGES.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1379270; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1379270. IFU REVIEW: 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. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. KINKING WAS NOTED ON PROXIMAL FLEXOR. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE CUSTOMER PLANNED TO PLACE EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED IN THE MIDDLE LOWER COMMON BILE DUCT. THE PATIENT'S ANATOMICAL FORM WAS VERY TORTUOUS AND IT MADE OPERATION OF ENDOSCOPE DIFFICULT. THE STENOSIS OF THE TARGET SITE WAS VERY SEVERE AND RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT AND INTRODUCER THROUGH THE OBSTRUCTED AREA. THEN HE ATTEMPTED TO PULL THE TRIGGER TO START STENT DEPLOYMENT, BUT HE COULD NOT PULL THE TRIGGER AT ALL. HE REPLACED THE DEVICE WITH ZILVER635 TO COMPLETE THE PROCEDURE. LAB EVALUATION PERFORMED ON THE 25 JULY 2018 CONFIRMED THE FLEXOR WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652205 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G23129 C1379270 10827002231297

    Patients

    Seq Age Sex Outcome Treatment
    1