BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 6759754 · Received August 2, 2017

    Report

    Report Number
    3001845648-2017-00310
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 5, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002231341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. EQUIVALENT RPNS VERIFIED FOR REGULATORY 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. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED: ¿WAS THERE RESISTANCE FELT INSERTING THE DEVICE INTO THE SCOPE OR PATIENT & WAS THE PATH TOTUROUS?¿ TO WHICH THE REP RESONDED 'NO'. 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 AT THE 5TH DIMPLE TOWARDS THE FRONT OF THE HANDLE. THERE WAS NO STENT EXPOSURE FROM THE SHEATH ON RETURN. DEPLOYMENT OR RETRACTION WAS NOT POSSIBLE. THERE WAS NO DAMAGE NOTED TO THE ZIP PORT DURING LAB EVALUATION. THE HANDLE WAS DISMANTLED DURING LAB EVALUATION TO SHOW THAT THE FLEXOR HAD BROKEN. THERE WAS A KINK IN THE FLEXOR WHICH POSSIBLY COULD HAVE CAUSED HIGH FORCES LEADING TO THE FLEXOR BREAKING. HEAVY RESISTANCE WAS NOTED WHEN ATTEMPTING TO DEPLOY THE STENT MANUALLY. THE KINK IN THE FLEXOR WAS STRAIGHTENED WHICH RELIEVED THE PRESSURE SLIGHTLY. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS BROKEN. AS USAGE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. POTENTIAL ROOT CAUSE FOR THIS ISSUE ARE AS FOLLOWS:" - DAMAGE DURING TRANSPORTATION - DAMAGE DURING OR PRIOR TO PACKAGING - HANDLING DAMAGE BY USER - EXCESSIVE FORCES APPLIED TO SYSTEM - INCOMPATIBLE ACCESSORY DEVICES OR SCOPE SELECTED." 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". 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

    THIS INITIAL REPORT IS BEING SUBMITTED DUE TO THE MALFUNCTION PRECEDENCE: FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED. THE STENT DID NOT OPEN CORRECTLY AND COULD NOT BE RELEASED, THERE WAS A CRACKING SOUND IN THE TRIGGER SYSTEM DURING ATTEMPT OF STENT RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539912 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED ESW COOK IRELAND LTD 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1