BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5637054 · Received May 6, 2016

    Report

    Report Number
    3001845648-2016-00122
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    February 18, 2016
    Report Date
    April 12, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    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. IT WAS ADVISED THAT THE DEVICE INVOLVED IN THIS COMPLAINT WAS AVAILABLE TO BE RETURNED FOR EVALUATION BUT TO-DATE THE DEVICE HAS NOT BEEN RECEIVED AT COOK (B)(4). THE DEVICE HAS NOT BEEN RECEIVED; THEREFORE THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IF THE DEVICE IS RECEIVED AT A LATER DATE, THE COMPLAINT FILE WILL BE UPDATED TO INCLUDE DETAILS OF THE COMPLAINT INVESTIGATION. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION, ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1124185 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE ADVISES THE USER OF THE FOLLOWING: ¿IF PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD INHIBIT PROPER WORKING CONDITION, DO NOT USE." FROM THE INFORMATION PROVIDED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 1

    THE EVOLUTION BILIARY STENT FAILED TO RELEASE FROM THE DEPLOYMENT SYSTEM. THE STENT WAS REMOVED AND REPLACED WITH A DIFFERENT STENT. THE USER CONFIRMED THE STENT WAS PARTIALLY EXPOSED WHEN REMOVING FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293188 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1