BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 3813561 · Received March 26, 2014

    Report

    Report Number
    3001845648-2014-00055
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 25, 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

    THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR PARTIAL STENT DEPLOYMENT WITH THE SAFETY LOCK IN PLACE, REGARDLESS OF PATIENT OUTCOME. THERE WERE NO ZILBS-635-8-8 DEVICES OF LOT C913399 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A 1 X ZILBS-635-8-8 DEVICE OF LOT C913399 WAS RETURNED FOR EVALUATION. IT WAS RETURNED IN ITS ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT A STENT WAS RETURNED PARTIALLY DEPLOYED IN THE DELIVERY SYSTEM. THE RED SAFETY LOCK WAS IN PLACE ON THE DEVICE. THERE WAS A KINK ON THE SHEATH EVIDENT AT APPROX 47CM. IT WAS NOTED THAT THE FLEXOR WAS SLIGHTLY STRETCHED AS IT MEASURED AROUND 200.8CM. THE CUSTOMER COMPLAINT COULD BE CONFIRMED AS TH E STENT WAS RETURNED PARTIALLY DEPLOYED IN THE SHEATH WITH THE RED SAFETY LOCK IN PLACE. THE KINK MAY HAVE OCCURRED IF FORCE WAS APPLIED DUE TO THE RESISTANCE FELT WHEN THE USER WAS ATTEMPTING TO ADVANCE THE DELIVERY SYSTEM INTO THE ENDOSCOPE. THIS MAY POSSIBLY HAVE RESULTED IN THE SHEATH COMPRESSING AND STRETCHING CAUSING THE STENT TO PARTIALLY DEPLOY WITH THE SAFETY LOCK IN. FROM THE DESCRIPTION PROVIDED, RESISTANCE WAS FELT WHEN THE DELIVERY SYSTEM TIP CAME OUT OF THE ENDOSCOPY TIP. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED AS WE CANNOT REPLICATE THE CONDITIONS OF USE IN THE LABORATORY. THE RELEVANT PERSONNEL HAVE BEEN INFORMED OF THIS COMPLAINT EVENT. AS PER THE INSTRUCTIONS FOR USE 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-635-8-8 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILBS-635-8-8 DEVICES OF LOT C913399 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FROM THE INFORMATION PROVIDED, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 1

    THE PATIENT HAD ROUX-EN-Y METHOD AFTER DUODENUM AND PANCREAS HEAD RESECTION AND A ZILVER 635 BILIARY SELF EXPANDING METAL STENT WAS PREVIOUSLY PLACED UNDER THE SAME CONDITIONS AT THIS TIME. THE PHYSICIAN USED A DOUBLE BALLOON ENDOSCOPE EI-530B AND ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM INTO THE BILE DUCT, BUT HE FELT RESISTANCE WHEN THE DELIVERY SYSTEM TIP JUST CAME OUT OF THE ENDOSCOPY TIP AND HE SAW THE STENT WAS PARTIALLY DEPLOYED WITH THE SAFETY LOCK ON. HE MANAGED TO RETRACT THE DEVICE IN THE SCOPE AND REPLACED IT WITH ANOTHER ZILVER 635 BILIARY SELF EXPANDING METAL STENT. THE REPLACEMENT COULD BE PLACED IN THE BILE DUCT SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179002 ZILVER 635 BILIARY SELF EXPANDING METAL STENT CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C913399

    Patients

    Seq Age Sex Outcome Treatment
    1