BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 6218287 · Received January 3, 2017

    Report

    Report Number
    3001845648-2017-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 3, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002231310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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. PMA/510(K)# OF SIMILAR DEVICE: K121430. AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-8-9-6-B OF LOT NUMBER C1267148 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL EVO-FC-8-9-6-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 (B)(4). 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.

    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. ON 05-JAN-2017: ON EVALUATION OF THE DEVICE, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED. THE LOCKWIRE WAS STILL IN PLACE. THE DISTAL FLEXOR WAS SLIGHTLY DAMAGED AND THE STENT WAS DISCONNECTED FROM THE INNER CATHETER. IT WAS NOT POSSIBLE TO RETRACT THE STENT BUT IT WAS POSSIBLE TO DEPLOY IT. THE SUTURE WAS PULLED BACK. ENGINEER COMMENTED THAT THE LOCKWIRE SHOULD BE CONNECTED THROUGH THE SUTURE. THE LOCKWIRE WAS NOT DAMAGED BUT APPEARED TO HAVE BEEN CUT TOO SHORT FROM THE DISTAL END. A SUBSEQUENT LAB EVALUATION WAS COMPLETED ON 20-JAN-2017 TO ASCERTAIN EXACT MEASUREMENTS FOR THE LOCK WIRE CUT TOO SHORT. DURING THIS LAB EVALUATION THE LOCKWIRE WAS PULLED UP AS FAR AS IT COULD BE AND MEASURED TO BE 6 MM FROM THE DISTAL MARKER WHICH IS OUT OF SPECIFICATION BY 3 MM. THE LOCKWIRE WAS INSPECTED FOR DAMAGE TO THE LOCK WIRE ASSEMBLY , INSIDE AND OUT, (DUE TO THE USER RELEASING THE LOCK WIRE FROM THE STENT) AND THE DISTAL END BEFORE PULLING IT FORWARD TO ENSURE THE MEASUREMENT TAKEN WAS ACCURATE. THE LOCK WIRE WAS THEN REMOVED FROM THE DEVICE FULLY AND THE ENTIRE LENGTH INSPECTED FOR DAMAGE TO ENSURE THE MEASUREMENT WAS NOT INFLUENCED BY DAMAGE TO THE LOCK WIRE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE LOCKWIRE WAS TOO SHORT. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-8-9-6-B OF LOT NUMBER C1267148 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL EVO-FC-8-9-6-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. 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 THE STENT WAS OPENED UP TO 60%. THE DOCTOR ATTEMPTED TO CLOSE THE STENT AGAIN. DOCTOR COULD NOT CLOSE THE STENT.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: IT WAS REPORTED THAT THE STENT WAS OPENED UP TO 60%. THE DOCTOR ATTEMPTED TO CLOSE THE STENT AGAIN. DOCTOR COULD NOT CLOSE THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 10827002231310

    Patients

    Seq Age Sex Outcome Treatment
    1