BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 3901919 · Received May 27, 2014

    Report

    Report Number
    3001845648-2014-00089
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K020788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ZILBS-635-8-4 (ZILVER BILIARY) DEVICES OF LOT NUMBER C850992 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A 1 X ZILBS-635-8-4 DEVICE OF LOT NUMBER C850992 WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT A STENT WAS RETURNED DEPLOYED. INFO REC'D STATED THAT "THE STENT WAS COMPLETELY RELEASED OUTSIDE THE PATIENT BY THE PHYSICIAN AFTER THE PROCEDURE". THE RED SAFETY LOCK WAS IN PLACE ON THE DEVICE. NO EVIDENCE OF TACTILE DAMAGE WAS NOTED DURING THE INSPECTION OF THE FLEXOR. THE INNER CATHETER WAS FOUND TO BE 11MM OUTSIDE OF THE FLEXOR. HOWEVER WHEN THE SAFETY LOCK WAS REMOVED AND THE HANDLE RETRACTED FULLY, THE INNER CATHETER RETRACTED FULLY INO THE FLEXOR. THERE WAS NO DAMAGE EVIDENT ON THE DEPLOYED STENT. COMMENTS PROVIDED BY THE PHYSICIAN STATED THAT "I DID NOT NOTICE THE EVENT DURING PREPARATION. SINCE THE USER WAS USED TO ZILBS, THE DEVICE MIGHT BE DEFECTIVE". COMMENTS PROVIDED BY THE SALES REP AND DEALER STATED THAT "I SUPPOSE THAT THE EVENT OCCURRED DUE TO USER'S TECHNICAL ERROR". A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED AS WE CANNOT REPLICATE THE CONDITIONS OF USE IN THE LABORATORY. AS PER THE INSTRUCTIONS FOR USE, IFU0065-1, THE USER IS ADVISED OF THE FOLLOWING: "PRIOR TO DEPLOYING STENT, REMOVE THE SAFETY LOCK. NOTE: ENSURE THAT THE SAFETY LOCK IS NOT INADVERTENTLY REMOVED UNTIL FINAL STENT PLACEMENT". PRIOR TO DISTRIBUTION ALL ZILBS-635-6-6 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILBS-635-8-4 DEVICE OF LOT NUMBER C850992 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FROM THE INFO PROVIDED, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS THE INCIDENT OCCURRED PRIOR TO PATIENT CONTACT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 1

    JUST BEFORE INSERTING THE DEVICE INTO AN ENDOSCOPIC CHANNEL, THE PHYSICIAN NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED, DESPITE THE SAFETY LOCK BEING IN PLACE-ONLY THE STENT TIP WAS DEPLOYED. ANOTHER DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311875 ZILVER 635 BILIARY SELF EXPANDING METAL STENT GFE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C850992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA