BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5404550 · Received February 2, 2016

    Report

    Report Number
    3001845648-2016-00024
    Event Type
    Malfunction
    Date Received
    February 2, 2016
    Date of Event
    January 8, 2015
    Report Date
    February 2, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PMA/510(K)# OF 'SIMILAR DEVICE': K121430.

    Additional Manufacturer Narrative · 1

    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. PMA/510(K)# OF 'SIMILAR DEVICE': K121430. UPON EVALUATION OF THE RETURNED DEVICE IT WAS NOTED THAT THE LOCK WIRE WAS BROKEN. THE LOCK WIRE ANCHOR ASSEMBLY WAS OPENED UP. THE LOCK WIRE ANCHOR, LOCK WIRE MLLA AND THE LOCK WIRE SCREW WERE ALL PRESENT. THE FLATTENED PART OF THE LOCKWIRE WAS EXAMINED UNDER THE MICROSCOPE. THE LOCK WIRE WAS BROKEN AT THE START OF THE CRIMP (FLATTENED PIECE). THE FLATTENED PIECE HAD A BEND ON IT. THE (B)(4) RESEARCH & DEVELOPMENT ENGINEER COMMENTED THAT THE FORCE AT WHICH IT BROKE IS UNKNOWN. AS THE ACTUAL USE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THIS COMPLAINT. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE LOCK WIRE WAS CONFIRMED TO BE BROKEN. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-10-11-8-B DEVICE OF LOT NUMBER C1157806 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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 (B)(4). 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.

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF AN EVOLUTION BILIARY STENT THE RED PIN OF THE SAFETY LOCK BROKE AWAY LEAVING ONLY A SMALL PIECE OF THE SAFETY WIRE EXPOSED. A FORCEPS HAD TO BE USED TO GRAB THE SAFETY WIRE TO REMOVE IT FULLY SO THAT THE STENT COULD BE DEPLOYED FROM THE DELIVERY SYSTEM. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE PATIENT. 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. EVENT MEETS FDA MDR REPORTING CRITERIA BASED ON THE MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY FOR THE ISSUE 'SAFETY WIRE BREAKAGE'. THE INVESTIGATION OF THIS EVENT IS CURRENTLY STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS WITH THE INVESTIGATION CONCLUSION.

    Description of Event or Problem · 1

    THIS FOLLOW UP MDR REPORT IS BEING SUBMITTED DUE TO THE CONCLUSION OF THE INVESTIGATION INTO THIS SPECIFIC EVENT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: DURING DEPLOYMENT OF AN EVOLUTION BILIARY STENT THE RED PIN OF THE SAFETY LOCK BROKE AWAY LEAVING ONLY A SMALL PIECE OF THE SAFETY WIRE EXPOSED. A FORCEPS HAD TO BE USED TO GRAB THE SAFETY WIRE TO REMOVE IT FULLY SO THAT THE STENT COULD BE DEPLOYED FROM THE DELIVERY SYSTEM. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE PATIENT. 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. EVENT MEETS FDA MDR REPORTING CRITERIA BASED ON THE MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY FOR THE ISSUE 'SAFETY WIRE BREAKAGE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63991 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention