BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 6515199 · Received April 24, 2017

    Report

    Report Number
    3001845648-2017-00134
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    March 27, 2017
    Report Date
    April 24, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506210
    PMA / PMN Number
    K020788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. 1X ZILBS-635-10-6 DEVICE OF LOT C1264654 WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. FROM THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. FROM ADDITIONAL INFORMATION RECEIVED, IT IS KNOWN THAT THE DEVICE WAS FIRST OPENED, CLEANED AND DISINFECTED WITH ENDOZIME. IT WAS THEN DECIDED THAT THE DEVICE WAS NOT NEEDED (WAS NOT DEPLOYED OR ATTEMPTED TO DEPLOY)AND THEREFORE WAS NOT USED ON THE PATIENT. 2 MONTHS LATER THE DEVICE WAS THEN USED ON THIS CURRENT PATIENT, AND THE DELIVERY CATHETER SNAPPED OUT FROM THE DEVICE. IT WAS ALSO STATED THAT THE PATIENT ANATOMY WAS NOT SEVERELY CALCIFIED. THE COMPLAINT DEVICE UNDERWENT A LABORATORY EVALUATION ON THE 13-APRIL-2017. ON EVALUATION OF THE RETURNED DEVICE THE OUTER SHEATH WAS DETACHED FROM THE HANDLE. THERE WAS NO PARTIAL DEPLOYMENT ON RETURN. THERE WAS A KINK IN THE INNER PEAK NEXT TO THE WHITE TIP. THE STENT WAS STILL IN THE SYSTEM. DEFORMATION/DAMAGE WAS NOTED ON THE DISTAL END OF THE TIP. TIP WAS ALSO BENT. THE STENT WAS THEN DEPLOYED BY PULLING THE OUTER SHEATH. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE OUTER SHEATH WAS DETACHED FROM THE HANDLE ON RETURN OF THE DEVICE FOR EVALUATION. A POSSIBLE ROOT CAUSE ON THIS OCCURRENCE MAY BE THE PATIENT ANATOMY, WHICH WAS NOTED TO BE CALCIFIED BUT NOT SEVERELY (IT CAN BE NOTED THAT AS PER THE LAB EVALUATION, THE TIP OF THE DEVICE WAS DAMAGED). IN ADDITION TO THIS, THE DEVICE WAS USED AFTER IT HAD BEEN PREVIOUSLY OPENED FOR 2 MONTHS. THIS IS CONSIDERED USER ERROR, AS THE DEVICE IS STATED TO BE FOR SINGLE USE ONLY AS PER THE INSTRUCTIONS FOR USE, (IFU0065-1). HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN THE LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. ALL ZILBS (ZILVER 635 BILIARY) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR LOT C1264654 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 AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1264654. THE CASE WAS COMPLETED BY USING A TAE-WOONG STENT AND CASE WAS REPORTED TO BE SUCCESSFUL. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR ANY POTENTIAL EMERGING TRENDS.

    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. INVESTIGATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED IN ORDER TO INCLUDE THE INVESTIGATION FINDINGS. THIS PARTICULAR STENT WAS CLEANED AND DISINFECTED PRIOR USE FOR A PATIENT BEFORE THIS, HOWEVER WAS NOT DEPLOYED OR ATTEMPT TO DEPLOY AS THE CONDITION OF THE PATIENT BEFORE THIS WASN'T PERMISSIBLE. SO, UPON USING IN THE CURRENT PATIENT, DR. HO SAID THAT THE DELIVERY CATHETER SNAPPED OUT FROM THE DEVICE WHILE THE NURSE WAS IN THE PROCESS OF DEPLOYING. THE CASE WAS THEN COMPLETED BY USING A TAE-WOONG STENT AND CASE WAS REPORTED TO BE SUCCESSFUL.

    Description of Event or Problem · 0

    THIS PARTICULAR STENT WAS CLEANED AND DISINFECTED PRIOR USE FOR A PATIENT BEFORE THIS, HOWEVER, WAS NOT DEPLOYED OR ATTEMPT TO DEPLOY AS THE CONDITION OF THE PATIENT BEFORE THIS WASN'T PERMISSIBLE. SO, UPON USING IN THE CURRENT PATIENT, DR. (B)(6) SAID THAT THE DELIVERY CATHETER SNAPPED OUT FROM THE DEVICE WHILE THE NURSE WAS IN THE PROCESS OF DEPLOYING. THE CASE WAS THEN COMPLETED BY USING A TAE-WOONG STENT AND CASE WAS REPORTED TO BE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298645 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002506210

    Patients

    Seq Age Sex Outcome Treatment
    1