BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 6917232 · Received October 5, 2017

    Report

    Report Number
    3001845648-2017-00441
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 7, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EQUIVALENT RPN'S VERIFIED FOR REG. CLEARANCE CHECKS. PMA/510(K) # 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. 1 X EVO-FC-10-11-6-B WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE IT WAS NOTED THAT THE LOCKWIRE WAS IN PLACE ON RETURN. THE RED SHUTTLE DEPLOYMENT MARKER WAS HALF WAY BACK THE HANDLE. THERE WAS NO STENT EXPOSURE ON RETURN OF THE DEVICE. A BEND WAS OBSERVED IN THE FLEXOR CLOSE TO THE HANDLE WHICH COULD HAVE OCCURRED ON TRANSPORTATION WHEN RETURNING THE DEVICE. THE HANDLE WAS DISMANTLED DURING LAB EVALUATION, IT WAS SEEN THAT THE FLEXOR WAS BROKEN. THE STENT WAS MANUALLY DEPLOYED AND NOTED TO BE FINE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS SEEN TO BE BROKEN IN THE LABORATORY. AS USAGE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE FLEXOR BROKE DUE TO EXCESSIVE FORCE. 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. 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". 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

    IMPOSSIBLE TO DEPLOY METALLIC STENT SYSTEM PROBABLY BROKEN INSIDE THE HANDLE NO PROBLEM WITH PATIENT THEY USED ANOTHER STENT FOR THIS CUSTOMER. "AS PER COMPLAINT FORM": DR PERFORMED SPHINCTEROTOMY WITHOUT PROBLEM AND GUIDE WIRE WAS IN THE GOOD POSITION. NURSE OPENED THE STENT PACKAGE AND REMOVED THE STENT FROM THE BOX WITHOUT PROBLEM. STENT SEEMED OK, THEY PRESSED THE RED BUTTON BEFORE TO INTRODUCE STENT THOUGHT THE SCOPE OPERATING CHANNEL. IT WAS VERY DIFFICULT TO PUT THE STENT IN THE CORRECT PLACE, DR PUSHED STRONGLY ON THE FLEXOR. WHEN THEY WERE IN THE GOOD POSITION IT WAS IMPOSSIBLE TO DEPLOY THE STENT, SYSTEM SEEMED BROKEN (BOTH WY) THEY REMOVED THE STEM FROM THE PATIENT AND TOOK ANOTHER ONE A SHORTER ONE NO PROBLEM WITH THE SECOND STENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698308 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1