BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 7672926 · Received July 10, 2018

    Report

    Report Number
    3001845648-2018-00312
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 12, 2018
    Report Date
    June 12, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002360133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K040505 / K163169. 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. PROBLEM STATEMENT: "PERCUTANEOUS METALLIC STENT PLACEMENT IN BILE DUCT BY APPROACH FROM ABDOMINAL REGION WAS PERFORMED. AFTER THE DELIVERY SYSTEM OF THE COMPLAINT ZIB6-40-10.0-80 REACHED THE TARGET LESION, DEPLOYMENT OF THE STENT WAS BEGUN. HOWEVER, DURING THE WITHDRAWAL OF THE HANDLE, THE OUTER SHEATH GOT SEPARATED FROM THE HANDLE. THE SYSTEM WAS RETRIEVED OUT OF THE BODY, ANOTHER DEVICE WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY." DEVICE EVALUATION: THE ZIB6-40-10.0-80 DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE PATIENT¿S ANATOMY WAS NOT CALCIFIED OR TORTUOUS. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 28TH JUNE 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE FLEXOR WAS SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. THE DEVICE WAS RETURNED WITH THE STENT STILL LOADED IN THE FLEXOR. THE STENT WAS RELEASED IN THE LAB, AND WAS MEASURED AS 8CM LONG. THE STENT WAS UNDAMAGED. THE FLEXOR LENGTH WAS 40.6CM, WHICH IS WITHIN SPECIFICATION 40CM +1.3CM -0.8CM. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE FLEXOR WAS FOUND TO BE SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE INSUFFICIENT STRENGTH OF THE FLEXOR TO WHITE CONNECTOR CAP JOINT. AS THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED RESISTANCE. THIS RESISTANCE COULD HAVE CAUSED OR CONTRIBUTED TO THE FLEXOR SEPARATING FROM THE HANDLE. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE PRODUCT PACKAGING INSERT. IT MAY BE NOTED THAT PROJECT IME-0035-BMS HAS BEEN INITIATED TO PREVENT THE REOCCURRENCE OF HANDLE/FLEXOR SEPARATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER BILIARY 635 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FQC. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 THIS LOT NUMBER. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE FLEXOR WAS FOUND TO BE SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. THE RISK WAS DETERMINED TO BE LOW (CATEGORY IIA). 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

    INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)¿. PERCUTANEOUS METALLIC STENT PLACEMENT IN BILE DUCT BY APPROACH FROM ABDOMINAL REGION WAS PERFORMED. AFTER THE DELIVERY SYSTEM OF THE COMPLAINT ZIB6-40-10.0-80 REACHED THE TARGET LESION, DEPLOYMENT OF THE STENT WAS BEGUN. HOWEVER, DURING THE WITHDRAWAL OF THE HANDLE, THE OUTER SHEATH GOT SEPARATED FROM THE HANDLE. THE SYSTEM WAS RETRIEVED OUT OF THE BODY, ANOTHER DEVICE WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517676 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1465990 10827002360133

    Patients

    Seq Age Sex Outcome Treatment
    1