BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 7263649 · Received February 12, 2018

    Report

    Report Number
    3001845648-2018-00057
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 15, 2018
    Report Date
    January 15, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506210
    PMA / PMN Number
    K020788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. TWO ZILBS-635-10-6 DEVICE OF LOT NUMBER C1376257 WERE RETURNED TO COOK IRELAND AND EVALUATED ON THE 01 FEBRUARY 2018. UPON EVALUATION OF THE RETURNED DEVICES, THE FOLLOWING WAS NOTED: DEVICE #1: THE FLEXOR WAS SEPARATED FROM THE HANDLE AT THE WHITE CAP. THERE WAS DAMAGE ON THE FLEXOR WHERE IT MEETS THE ENDOSCOPE ELEVATOR. THE FLEXOR LENGTH MEASURED 200.7CM, WHICH WAS WITHIN SPECIFICATION OF 200CM +2/-1CM. THERE WAS NO DAMAGE NOTED TO THE WHITE TIP. THE DEVICE WIRED FREELY WITH A 0.035¿ WIREGUIDE. THE STENT WAS DEPLOYED AND MEASURED 60MM. NO ISSUES WERE NOTED TO THE STENT. INNER PEAK WAS NOTED TO BE BENT WHICH CORRESPONDS TO THE DAMAGE NOTED WHERE THE FLEXOR MEETS THE ENDOSCOPE ELEVATOR. NO MANUFACTURING DEFECTS WERE NOTED. DEVICE #2: THE FLEXOR WAS SEPARATED FROM THE HANDLE AT THE WHITE CAP. THERE WAS DAMAGE ON THE FLEXOR WHERE IT MEETS THE ENDOSCOPE ELEVATOR. THE FLEXOR LENGTH MEASURED 201CM, WHICH WAS WITHIN SPECIFICATION OF 200CM +2/-1CM. THERE WAS NO DAMAGE NOTED TO THE WHITE TIP. THE DEVICE WAS FLUSHED AND WIRED FREELY WITH A 0.035¿ WIREGUIDE. THE STENT WAS DEPLOYED AND MEASURED 60MM. NO ISSUES WERE NOTED TO THE STENT. INNER PEAK WAS NOTED TO BE BENT WHICH CORRESPONDS TO THE DAMAGE NOTED WHERE THE FLEXOR MEETS THE ENDOSCOPE ELEVATOR. NO MANUFACTURING DEFECTS WERE NOTED. THE FOLLOWING ADDITIONAL INFORMATION WAS ALSO PROVIDED IN THE COMPLAINT FILE: SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE. DILATION OF THE OBSTRUCTED AREA BEEN PERFORMED PRIOR TO THIS OCCURRENCE. THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WAS OLYMPUS/ TJF-260V. THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED WAS THE RIGHT HEPATIC DUCT IN THE PORTA HEPATIS REGION. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE OBSTRUCTED AREA. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT AND INTRODUCER THROUGH THE OBSTRUCTED AREA. NO SECTION OF THE DEVICE DETACHED INSIDE THE ENDOSCOPE OR PATIENT. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT ZILVER (10-4). COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE FLEXOR WAS SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE TORTUOUS PATIENT ANATOMY, OR INSUFFICIENT STRENGTH OF THE FLEXOR. THE ANATOMY COULD HAVE CREATED THE RESISTANCE FELT DURING DEPLOYMENT. INSUFFICIENT STRENGTH IN THE FLEXOR COULD HAVE CAUSED OR CONTRIBUTED TO THE OUTER SHEATH (FLEXOR) DISCONNECTING FROM THE HANDLE AS A RESULT OF THE RESISTANCE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE PRODUCT PACKAGING INSERT. IT MAY BE NOTED THAT A PROJECT HAS BEEN INITIATED TO PREVENT THE REOCCURRENCE OF OUTER SHEATH SEPARATION FROM THE HANDLE. PRIOR TO DISTRIBUTION, ALL ZILBS (ZILVER BILIARY) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED TO DATE, THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1376257. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AFTER INSERTING AN ERCP CATHETER IN THE RIGHT BILE DUCT, A WIRE GUIDE WAS PLACED FOR STENT PLACEMENT IN THE RIGHT HEPATIC DUCT. THE FIRST STENT: DELIVERY SYSTEM OF ZILVER STENT WAS ADVANCED OVER THE WIRE GUIDE AND PASSED BEYOND THE STENOSED SITE SMOOTHLY WITHOUT ANY RESISTANCE. RIGHT AFTER THE PHYSICIAN STARTED TO PULL THE HANDLE IN ORDER TO DEPLOY THE STENT, THE OUTER SHEATH GOT SEPARATED FROM THE WHITE CONNECTOR CAP OF THE HANDLE. THEREFORE, THE DELIVERY SYSTEM WITH THE STENT UNDEPLOYED WAS REMOVED AND CHANGED WITH ANOTHER ZILVER STENT OF THE SAME LOT#. THE SECOND STENT: ANOTHER ZILVER STENT OF THE SAME LOT# AS THE FIRST DEVICE WAS USED INSTEAD, BUT THE SAME EVENT OCCURRED. THE DEVICE WAS REMOVED FROM THE PATIENT AND CHANGED WITH ZILVER 635 (10-4). THE REPLACEMENT ZILVER (10-4) COULD BE USED WITHOUT ANY PROBLEM AND THE STENT WAS PLACED. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT ZILVER (10-4), AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108652 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G50621 10827002506210

    Patients

    Seq Age Sex Outcome Treatment
    1