BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM

    MDR report key: 2980051 · Received February 21, 2013

    Report

    Report Number
    1037905-2013-00065
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FGE
    PMA / PMN Number
    K020788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT OF INTRODUCER SEPARATION. THE INTRODUCER WAS RETURNED IN TWO SECTIONS - ONE SECTION WAS THE INTRODUCER HANDLE WITH THE OUTER TUBING ATTACHED AND THE OTHER SECTION WAS THE PUSHING CATHETER WITH THE TIP ATTACHED. IT WAS NOTED THAT THE PROXIMAL PORTIONS OF THE HANDLE ASSEMBLY OF THE INTRODUCER WERE NOT INCLUDED IN THE RETURN. DURING THE VISUAL EXAMINATION OF THE PUSHING CATHETER, IT WAS NOTED THAT THE TIP WAS DAMAGED - A SMALL SECTION AT THE PROXIMAL END OF THE TIP APPEARED TO BE RIPPED. IT WAS ALSO NOTED THAT TWO SECTIONS OF THE DISTAL END OF THE PUSHING CATHETER WERE DAMAGED. THE DISTAL END WAS EXTENSIVELY FLATTENED, DENTED, AND KINKED. THE EVAL THEN INVOLVED VERIFYING THE ASSEMBLY OF THE JOINTS OF THE PROXIMAL CATHETER WITH THE DISTAL TUBING. USING A VIDEO INSPECTION SYSTEM, THE PROXIMAL TIP OF THE CATHETER WAS EXAMINED UNDER MAGNIFICATION. IT WAS CONFIRMED THAT IT MET ALL MANUFACTURING REQUIREMENTS AND NO DISCREPANCIES WERE NOTED. THE DISTAL TIP OF THE TUBING WAS THEN ANALYZED UNDER MAGNIFICATION AND IT WAS CONFIRMED THAT IT MET ALL MANUFACTURING REQUIREMENTS AND NO DISCREPANCIES WERE NOTED. IT WAS ALSO EVIDENT THAT THE END OF THE TUBING HAD BEEN MANUFACTURED FOLLOWING ALL MANUFACTURING REQUIREMENTS AND NO DISCREPANCIES WERE NOTED. THEREFORE, WE CAN CONCLUDE THAT NO DISCREPANCIES WERE FOUND WHERE THE SEPARATION OCCURRED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO THE CONDITION OF THE RETURNED PRODUCT AND A VARIETY OF CLINICAL CONDITIONS, SUCH AS PT ANATOMY OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. INSTRUCTIONS FOR USE INFO STATES: PRIOR TO USE, VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS, AND BREAKS; IF THE WIRE GUIDE OR STENT CANNOT ADVANCE THROUGH THE OBSTRUCTED AREA, DO NOT ATTEMPT TO PLACE THE STENT; NOTE: IT IS RECOMMENDED TO RE-ADVANCE THE OUTER SHEATH TO ITS PRE-DEPLOYED POSITION PRIOR TO REMOVING THE SYSTEM. PRIOR TO DISTRIBUTION, ALL ZILVER BILIARY STENT SYSTEMS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE BILE DUCT, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. AFTER RELEASING THE STENT, THE END OF THE INTRODUCER BROKE WHEN THE SYSTEM WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, THE STENT WAS IMPLANTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75582 ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM FGE, CATHETER, BILIARY, DIAGNOSTIC FGE WILSON-COOK MEDICAL INC W3197756

    Patients

    Seq Age Sex Outcome Treatment
    1 VISIGLIDE 25 WIREGUIDE| DUODENOSCOPE: OLYMPUS 160