BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 6101572 · Received November 15, 2016

    Report

    Report Number
    3001845648-2016-00325
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    August 12, 2016
    Report Date
    October 19, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PMA/510(K)# OF SIMILAR DEVICE: K121430. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS EVIDENT THAT THE LOCKWIRE WAS SLIGHTLY RELEASED, IT WAS NOTED THAT IT WAS RELEASED ENOUGH TO DEPLOY THE STENT AND IT WAS LOOSE. THE STENT WAS NOT RETURNED WITH THE DELIVERY SYSTEM. ACTUATION OF THE DEVICE WAS POSSIBLE. THE DELIVERY SYSTEM WAS RETURNED IN 2 PIECES. A PIECE OF THE DELIVERY SYSTEM WAS BROKEN AND DETACHED AT THE POLYIMIDE. THERE WERE KINKS EVIDENT ALONG THE POLYIMIDE PIECE THAT WAS RETURNED DETACHED. A WIRE GUIDE WAS PUT THROUGH THE DETACHED PIECE AND IT PASSED THE YELLOW MARKER AND STOPPED. THE YELLOW MARKER WAS OUT OF POSITION BY APPROXIMATELY 9MM, IT HAD MOVED FORWARD. THE POLYIMIDE BROKE UNDERNEATH THE INNER CLEAR TUBE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THERE WERE KINKS EVIDENT ALONG THE POLYIMIDE AND IT HAD DETACHED FROM THE DELIVERY SYSTEM. AS USAGE CONDITIONS COULD NOT BE REPLICATED WITHIN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVOLUTION DEVICE OF LOT C1242828 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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 · 1

    IT WAS REPORTED THAT WHEN IT BROKE, THE PROXIMAL DELIVERY PORTION WAS WITHDRAWN FROM THE SCOPE IN THE USUAL FASHION. TO RETRIEVE THE REMAINING DELIVERY SYSTEM, THE PHYSICIAN NEEDED TO GRAB IT WITH RAT TOOTH FORCEPS AND THEN PUSH THIS DOWN THE LUMEN OF THE BOWEL DISTALLY, SO THAT THE REMAINING PART OF THE DELIVERY MECHANISM CAME OUT THROUGH THE STENT, AT SUCH AN ANGLE WITHOUT DISLODGING THE STENT. THEN IT WAS PULLED OUT WITH THE ENDOSCOPE, WITH THE PARTS DANGLING FROM THE END OF THE SCOPE HELD WITH THE RAT TOOTH FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752592 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1