BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION ZILVER BILIARY STENT SYSTEM

    MDR report key: 2102283 · Received April 11, 2011

    Report

    Report Number
    1037905-2011-00283
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 11, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FGE
    PMA / PMN Number
    K040930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. APPROXIMATELY 3MM OF THE STENT IS EXTENDING FROM THE DISTAL END OF THE STENT DELIVERY SYSTEM. IT APPEARS THAT A 3MM SECTION OF THE STENT HAS DETACHED AND WAS NOT INCLUDED WITH THE RETURN. THE REMAINDER OF THE STENT REMAINS LOADED INSIDE THE STENT DELIVERY SYSTEM. THE CLEAR CAP ON THE STENT DELIVERY SYSTEM HANDLE REMAINS TIGHT ON THE Y-BODY. THE DISTANCE BETWEEN THE Y-BODY AND WIRE GUIDE PORT HUB MEASURES APPROXIMATELY 18CM. THE SPECIFICATION FOR THIS MEASUREMENT INDICATES THIS DISTANCE SHOULD BE 19.5CM +/- 0.5CM. THEREFORE THE HANDLE MAY HAVE BEEN ADVANCED, PERHAPS INADVERTENTLY, CAUSING THE STENT TO PREMATURELY DEPLOY. A REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. CONCLUSIONS: PARTIAL STENT DEPLOYMENT CAN OCCUR IF EXCESSIVE PRESSURE IS APPLIED TO THE HANDLE OF THE DELIVERY SYSTEM PERHAPS IN RESPONSE TO RESISTANCE ENCOUNTERED DURING CANNULATION. THE INFORMATION PROVIDED WITH THIS REPORT INDICATES RESISTANCE WAS ENCOUNTERED WHEN THE WIRE GUIDE AND STENT INTRODUCTION SYSTEM WERE ADVANCED INTO POSITION. RESISTANCE OF THIS NATURE CAN OCCUR IF THE STENT SYSTEM IS ADVANCED THROUGH A SEVERE STRICTURE. THE CONTRAINDICATIONS LISTED IN THE INSTRUCTIONS FOR USE INCLUDE INABILITY TO PASS THE WIRE GUIDE OR STENT THROUGH THE OBSTRUCTED AREA. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO ATTEMPT STENT PLACEMENT IF THE WIRE GUIDE OR STENT CANNOT BE ADVANCED THROUGH THE OBSTRUCTED AREA. IF EXCESSIVE PRESSURE WAS APPLIED TO THE DELIVERY SYSTEM, PERHAPS IN RESPONSE TO RESISTANCE DURING ADVANCEMENT, THIS COULD HAVE CONTRIBUTED TO PARTIAL STENT DEPLOYMENT. FRAGMENTATION OF THE STENT CAN OCCUR IF THE STENT IS REMOVED AFTER PLACEMENT. INFORMATION PROVIDED INDICATED THE PARTIALLY DEPLOYED STENT AND INTRODUCTION SYSTEM WERE REMOVED FROM THE PATIENT'S BODY AS ONE UNIT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: "THIS STENT IS NOT INTENDED TO BE REMOVED. ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO THE SURROUNDING MUCOSA. THIS STENT IS CONSIDERED TO BE A PERMANENT IMPLANT." THE INFORMATION PROVIDED INDICATED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PRIOR TO DISTRIBUTION, ALL FUSION ZILVER BILIARY STENT SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE INFORMATION PROVIDED INDICATED THE PRODUCT WAS USED IN CONTRADICTION WITH THE INSTRUCTIONS FOR USE. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    ON 4/6/2011, THE FOLLOWING INFORMATION WAS PROVIDED TO COOK ENDOSCOPY: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT, THE PHYSICIAN USED A COOK FUSION ZILVER BILIARY STENT SYSTEM. THE STENT PARTIALLY DEPLOYED FROM THE INTRODUCTION SYSTEM DURING POSITIONING. THE STENT AND INTRODUCTION SYSTEM WERE REMOVED FROM THE ENDOSCOPE AS ONE UNIT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ON 4/11/2011, THE PRODUCT WAS RETURNED FOR EVALUATION. UPON EVALUATION, WE CONFIRMED APPROXIMATELY 3MM OF THE STENT WAS MISSING. ALTHOUGH THE INITIAL REPORT INDICATED THAT NO PORTION OF THE DEVICE DETACHED INSIDE THE PATIENT, THE INFORMATION ON THE LOCATION OF THE MISSING SECTION OF THE STENT WAS REQUESTED, BUT WAS UNABLE TO BE PROVIDED. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION ZILVER BILIARY STENT SYSTEM FGE, CATHETER, BILIARY, DIAGNOSTIC FGE WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTAX ENDOSCOPE (UNKNOWN MODEL NUMBER)