BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 7125163 · Received December 18, 2017

    Report

    Report Number
    3001845648-2017-00594
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 22, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE: ¿STENT DIDN¿T DEPLOY. STENT WAS INTRODUCED OVER OLYMPUS VISIGLIDE IN COMMON HEPATIC DUCT THROUGH STENOSIS IN CBD. WHEN TRYING TO DEPLOY STENT, STENT DIDN¿T DEPLOY, PRESSURE WAS BUILT UP THROUGH THE DEPLOYMENT SYSTEM, DOCTOR DECIDED TO WITHDRAW THE SYSTEM TO AVOID POSSIBLE SUDDEN ¿JUMP¿ OF STENT. OUTSIDE THE PATIENT THEY DISCOVERED AFTER SHAKING THE SYSTEM THAT THE STENT SEEMED TO BE STUCK IN THE CATHETER, IT CAME OUT EVENTUALLY BUT AT THAT TIME THE DOCTOR ALREADY USED ANOTHER EVOLUTION. NO HARM TO PATIENT. PROCEDURE FINISHED WITH ANOTHER STENT EVO. NO PARTS LEFT IN BODY¿. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ¿(B)(4): 1) DID THE PHYSICIAN NOTICE ANY DAMAGE TO THE HANDLE OR NOISES COMING FROM THE HANDLE WHEN HE ATTEMPTED TO DEPLOY THE STENT? NOT NOTICED ¿ 1 X EVO-FC-10-11-6-B WAS RETURNED 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 FRONT OF THE HANDLE. THERE WAS NO STENT EXPOSURE FROM THE SHEATH ON RETURN OF THE DEVICE. THERE WAS SLIGHT DAMAGE AND A KINK OBSERVED ON THE FLEXOR POSSIBLY DUE TO HANDLING ON INSERTION INTO THE SCOPE. ADVANCEMENT AND RETRACTION WERE POSSIBLE WITH SLIGHT PRESSURE FELT. THE STENT WAS DEPLOYED DURING LAB WITH RESISTANCE FELT WHILE DEPLOYING DUE TO THE KINK PRESENT ON THE FLEXOR. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FAILURE WAS CONFIRMED IN THE LABORATORY; THE FLEXOR WAS SEEN TO BE KINKED. 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 KINK ON THE FLEXOR OCCURRED ON INSERTION INTO SCOPE WHICH CAUSED PRESSURE TO BUILD UP MAKING IT MORE DIFFICULT TO DEPLOY. A REVIEW OF THE QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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 EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-6-B DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT #, UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #. 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". STENT DIDN¿T DEPLOY. STENT WAS INTRODUCED OVER OLYMPUS VISIGLIDE IN COMMON HEPATIC DUCT THROUGH STENOSIS IN CBD. WHEN TRYING TO DEPLOY STENT, STENT DIDN¿T DEPLOY, PRESSURE WAS BUILT UP THROUGH THE DEPLOYMENT SYSTEM, DOCTOR DECIDED TO WITHDRAW THE SYSTEM TO AVOID POSSIBLE SUDDEN ¿JUMP¿ OF STENT. OUTSIDE THE PATIENT THEY DISCOVERED AFTER SHAKING THE SYSTEM THAT THE STENT SEEMED TO BE STUCK IN THE CATHETER, IT CAME OUT EVENTUALLY BUT AT THAT TIME THE DOCTOR ALREADY USED ANOTHER EVOLUTION. NO HARM TO PATIENT. PROCEDURE FINISHED WITH ANOTHER STENT EVO. NO PARTS LEFT IN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903441 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