BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 5113061 · Received September 30, 2015

    Report

    Report Number
    3001845648-2015-00190
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    August 7, 2015
    Report Date
    September 2, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT MEETS REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR 'DEPLOYMENT ISSUE RESULTING IN EXPOSED STENT REMOVED FROM PATIENT WITH THE DELIVERY SYSTEM' REGARDLESS OF PATIENT OUTCOME. THIS COMPLAINT IS RELATED TO 1 X EVO-10-11-10-B OF LOT#C970187. 1 X EVO-10-11-10-B DEVICE OF LOT# C970187 WAS RETURNED FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE STENT WAS PARTIALLY EXPOSED. THERE WERE NUMEROUS KINKS EVIDENT ALONG THE SHEATH OF THE DEVICE. THE CIRL RESEARCH & DEVELOPMENT ENGINEER NOTED THAT THE LOCKWIRE WAS PARTLY OUT OF THE DEVICE. IT WAS EVIDENT THAT THE INNER CANNULA WAS PROTRUDING APPROXIMATELY 10MM OUT AT THE LOCKWIRE AREA. THERE WAS A BIG BEND EVIDENT ALONG THE SHEATH. THIS LOCATION WOULD COINCIDE WITH WHERE THE DEVICE WOULD HAVE EXITED THE SCOPE. THERE WAS ALSO EXTREME STRETCHING EVIDENT NEAR THE CAP. THE HANDLE OF THE DEVICE WAS ACTUATED BUT THE STENT WOULD NOT DEPLOY. WHEN THE TRIGGER WAS ACTUATED THERE WAS RESISTANCE EXPERIENCED. THE DEVICE WAS DISMANTLED. IT WAS OBSERVED THAT THE RETRIEVAL LOOP CANNULA TO THE INNER FILLER CANNULA WAS BROKEN. IT IS UNSURE WHEN THIS COULD HAVE OCCURRED, POSSIBLE HIGH FORCE MAY HAVE BEEN APPLIED. THERE WAS NO ISSUES NOTED WITH THE STENT WHEN IT WAS DEPLOYED MANUALLY. THE CIRL RESEARCH & DEVELOPMENT ENGINEER CONCLUDED THAT THE BENDING IN THE INTRODUCER OCCURRED DURING THE PROCEDURE AND DID NOT OCCUR WHEN THE PRODUCT WAS BEING SHIPPED BACK. A DEFINITIVE CAUSE FOR THE REPORTED ISSUE WAS UNABLE TO BE DETERMINED AS THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. HOWEVER THE CIRL RESEARCH & DEVELOPMENT ENGINEER COMMENTED THAT THE BENDING IN THE INTRODUCER MOST LIKELY OCCURRED DURING THE PROCEDURE, AND THIS IN TURN WAS THE CAUSE OF THE INABILITY TO DEPLOY THE STENT AND THE OTHER DAMAGE TO THE DEVICE. THE BENDING JAMMED THE INNER PUSHER INSIDE THE OUTER SHEATH. THE CUSTOMER COMPLAINT COULD BE CONFIRMED AS THE FLEXOR WAS KINKED AND THE STENT WOULD NOT DEPLOY. PRIOR TO DISTRIBUTION ALL EVO-10-11-10-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-10-11-10-B DEVICE OF LOT NUMBER C970187 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE NOTES SECTION OF INSTRUCTIONS FOR USE 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". FROM THE INFORMATION PROVIDED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS. INCIDENT MEETS REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR 'DEPLOYMENT ISSUE RESULTING IN EXPOSED STENT REMOVED FROM PATIENT WITH THE DELIVERY SYSTEM' REGARDLESS OF PATIENT OUTCOME.

    Description of Event or Problem · 1

    THE DOCTOR TRIED UNSUCCESSFULLY TO DEPLOY AN EVO-10-11-10-B STENT WITH ANOTHER EXISTING STENT IN THE BILE DUCT. IT WAS IMPOSSIBLE TO POSITION THE NEW METAL STENT. THE TRIGGER FOR POSITIONING & DEPLOYING THE STENT DID NOT WORK CORRECTLY. UNABLE TO PERFORM THE PROCEDURE AND PLACE THE SECOND STENT. A DECLOGGING OF THE OLD STENT WITH A BILIARY ENDOSCOPIC EXTRACTOR HAS BEEN DONE TO ALLOW PERMEABILITY AND BILE FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645938 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1