BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 7537151 · Received May 23, 2018

    Report

    Report Number
    3001845648-2018-00236
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    April 26, 2018
    Report Date
    May 23, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002372709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    US CLEARANCE # 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: "AFTER THE PROCEDURE OF FLUSHING AND LOCATION, THE USER READY TO DEPLOY THE STENT, BUT DURING THIS PROCESS, THE INTRODUCER CATHETER WAS SEPARATE FROM THE JOINT OF THE HANDLE. SO THE STENT COULD NOT DEPLOY. THEN THE USER REMOVED THE DELIVERY SYSTEM AND REPLACED ANOTHER NEW SAME TYPE OF DEVICE TO FINISH THE PROCEDURE SUCCESSFULLY." DEVICE EVALUATION: THE ZIB6-40-8-6.0 DEVICE INVOLVED IN THIS COMPLAINT HAS NOT YET BEEN RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE CUSTOMER WAS CONTACTED TO RETURN THE DEVICE, AND TO REQUEST ADDITIONAL INFORMATION. THE INVESTIGATION WILL BE UPDATED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED, OR THE INFORMATION IS PROVIDED. THE CUSTOMER PROVIDED IMAGES OF THE COMPLAINT DEVICE. THE IMAGES SHOW THAT THE DEVICE FLEXOR HAD SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGES PROVIDED BY THE CUSTOMER. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE A DIFFICULT PATIENT ANATOMY. IF THE PATIENT¿S ANATOMY WAS SEVERELY CALCIFIED OR TORTUOUS, IT COULD HAVE CREATED RESISTANCE DURING DEPLOYMENT. THE RESISTANCE COULD HAVE CAUSED OR CONTRIBUTED TO THE FLEXOR SEPARATING FROM THE HANDLE, AND PREVENTED STENT DEPLOYMENT. HOWEVER, AS THE DEVICE HAS NOT YET BEEN RETURNED, AND 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 INSTRUCTIONS FOR USE. 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 635 BILIARY 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 IMAGES PROVIDED BY THE CUSTOMER.THE RISK WILL BE ASSESSED FOR THIS COMPLAINT ONCE THE DEVICE IS RETURNED AND EVALUATED. WHEN THE RISK HAS BEEN ASSESSED THE INVESTIGATION WILL BE UPDATED WITH THE RISK DETAILS. 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.

    Additional Manufacturer Narrative · 0

    US CLEARANCE # K040505 K163169. (B)(4). EXEMPTION NUMBER: E2016031 (B)(4). PROBLEM STATEMENT: "AFTER THE PROCEDURE OF FLUSHING AND LOCATION, THE USER READY TO DEPLOY THE STENT, BUT DURING THIS PROCESS, THE INTRODUCER CATHETER WAS SEPARATE FROM THE JOINT OF THE HANDLE. SO THE STENT COULD NOT DEPLOY. THEN THE USER REMOVED THE DELIVERY SYSTEM AND REPLACED ANOTHER NEW SAME TYPE OF DEVICE TO FINISH THE PROCEDURE SUCCESSFULLY." DEVICE EVALUATION: THE ZIB6-40-8-6.0 DEVICE OF LOT NUMBER C1362973 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. THE CUSTOMER PROVIDED IMAGES OF THE COMPLAINT. THE IMAGES SHOW THAT THE DEVICE FLEXOR HAD SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 17TH MAY 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED WITH THE STENT PARTIALLY DEPLOYED. THE FLEXOR WAS FOUND TO BE SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. THE FLEXOR LENGTH WAS 41CM, WHICH WAS WITHIN SPECIFICATION OF 40CM +1.3CM -0.8CM. THE STENT WAS RELEASED IN THE LAB. THE STENT WAS NOT DAMAGED, AND WAS 6CM LONG. RESISTANCE WAS ENCOUNTERED WHEN PASSING A 0.035¿ DIAMETER WIRE GUIDE THROUGH THE DEVICE. A WHITE SALT-LIKE SUBSTANCE CREATED A BLOCKAGE IN THE INNER DEVICE LUMEN. ONCE THE BLOCKAGE WAS REMOVED, THE WIRE COULD PASS THROUGH THE DEVICE WITHOUT RESISTANCE. 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 JOINT BETWEEN THE FLEXOR AND THE WHITE CAP. IT IS POSSIBLE THAT THE COMPLAINT DEVICE ENCOUNTERED RESISTANCE DURING DEPLOYMENT. SUCH RESISTANCE, ALONG WITH THE INSUFFICIENT JOINT STRENGTH, COULD HAVE CAUSED OR CONTRIBUTED TO THE FLEXOR SEPARATING FROM THE HANDLE, AND THE INABILITY TO DEPLOY THE STENT. 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 INSTRUCTIONS FOR USE. 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 635 BILIARY DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (B)(4) 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 LOT NUMBER C1362973. 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)". AFTER THE PROCEDURE OF FLUSHING AND LOCATION, THE USER READY TO DEPLOY THE STENT, BUT DURING THIS PROCESS, THE INTRODUCER CATHETER WAS SEPARATE FROM THE JOINT OF THE HANDLE. SO THE STENT COULD NOT DEPLOYED. THEN THE USER REMOVED THE DELIVERY SYSTEM AND REPLACED ANOTHER NEW SAME TYPE OF DEVICE TO FINISH THE PROCEDURE SUCCESSFULLY.

    Description of Event or Problem · 0

    FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE INVESTIGATION AND RISK ASSESSMENT DETAILS. INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)". AFTER THE PROCEDURE OF FLUSHING AND LOCATION, THE USER READY TO DEPLOY THE STENT, BUT DURING THIS PROCESS, THE INTRODUCER CATHETER WAS SEPARATE FROM THE JOINT OF THE HANDLE. SO THE STENT COULD NOT DEPLOYED. THEN THE USER REMOVED THE DELIVERY SYSTEM AND REPLACED ANOTHER NEW SAME TYPE OF DEVICE TO FINISH THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379718 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002372709

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR