BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 7108352 · Received December 12, 2017

    Report

    Report Number
    3001845648-2017-00586
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 13, 2017
    Report Date
    March 5, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002362298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. PMA/510(K) # K051124 / K163169. THE ZIB6-80-12.0-40 DEVICE OF LOT NUMBER C1060221 INVOLVED IN THIS COMPLAINT HAS NOT YET BEEN RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, THE COMPLAINT DEVICE WAS ADVANCED OVER AN UNKNOWN WIRE GUIDE. THE DEVICE WAS FLUSHED PRIOR TO USE. THE STENT WAS NOT DEPLOYED, NOR DID ANY PORTION OF THE STENT REMAIN IN THE PATIENT. IT IS NOT KNOWN IF THE PATIENT¿S ANATOMY WAS CALCIFIED OR TORTUOUS, OR IF PREDILATION WAS CONDUCTED PRIOR TO THIS OCCURRENCE. THE CUSTOMER CONFIRMED THAT THE HANDLE WAS PULLED TOWARDS THE HUB DURING DEPLOYMENT. THE CUSTOMER CONFIRMED THAT THE COMPLAINT DEVICE WAS USED IN THE ILIAC ARTERIES, AND THAT THE FLEXOR SHEATH CAME APART FROM THE HUB OF THE DELIVERY SYSTEM. THE CUSTOMER HAS CONFIRMED THAT THE DEVICE IS BEING RETURNED THE INVESTIGATION WILL BE UPDATED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE A DIFFICULT PATIENT ANATOMY, OR THE USE IN A NON-INDICATED LOCATION. IT IS NOT KNOWN IF THE PATIENT'S ANATOMY WAS CALCIFIED OR TORTUOUS. THE CUSTOMER STATED THAT THE COMPLAINT DEVICE WAS USED IN THE ILIAC ARTERIES. THESE FACTORS COULD CREATE RESISTANCE DURING DEPLOYMENT, AND COULD CAUSE OR CONTRIBUTE TO THE INABILITY TO DEPLOY THE DEVICE. HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED, AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. AS PER THE PRODUCT INSTRUCTIONS FOR USE: "THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE." PRIOR TO DISTRIBUTION ALL ZILVER BILIARY 635 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. 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 LOT NUMBER C1060221. IT MAY BE NOTED THAT THE FAILURE MODE OF "HANDLE FLEXOR SEPARATION - OFF LABEL USE" HAS BEEN PROVISIONALLY ASSIGNED. THE FINAL FAILURE MODE WILL BE CONFIRMED FOLLOWING DEVICE RETURN AND EVALUATION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE STENT WOULD NOT DEPLOY. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER STENT.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) # K051124 / K163169. THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT THE DEVICE HAS BEEN RECEIVED AND A LAB EVALUATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITHIN 30 DAYS WITH THE FINAL INVESTIGATION CONCLUSIONS. INITIAL REPORT INVESTIGATION: THE ZIB6-80-12.0-40 DEVICE OF LOT NUMBER C1060221 INVOLVED IN THIS COMPLAINT HAS NOT YET BEEN RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, THE COMPLAINT DEVICE WAS ADVANCED OVER AN UNKNOWN WIRE GUIDE. THE DEVICE WAS FLUSHED PRIOR TO USE. THE STENT WAS NOT DEPLOYED, NOR DID ANY PORTION OF THE STENT REMAIN IN THE PATIENT. IT IS NOT KNOWN IF THE PATIENT¿S ANATOMY WAS CALCIFIED OR TORTUOUS, OR IF PREDILATION WAS CONDUCTED PRIOR TO THIS OCCURRENCE. THE CUSTOMER CONFIRMED THAT THE HANDLE WAS PULLED TOWARDS THE HUB DURING DEPLOYMENT. THE CUSTOMER CONFIRMED THAT THE COMPLAINT DEVICE WAS USED IN THE ILIAC ARTERIES, AND THAT THE FLEXOR SHEATH CAME APART FROM THE HUB OF THE DELIVERY SYSTEM. THE CUSTOMER HAS CONFIRMED THAT THE DEVICE IS BEING RETURNED THE INVESTIGATION WILL BE UPDATED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE A DIFFICULT PATIENT ANATOMY, OR THE USE IN A NON-INDICATED LOCATION. IT IS NOT KNOWN IF THE PATIENT'S ANATOMY WAS CALCIFIED OR TORTUOUS. THE CUSTOMER STATED THAT THE COMPLAINT DEVICE WAS USED IN THE ILIAC ARTERIES. THESE FACTORS COULD CREATE RESISTANCE DURING DEPLOYMENT, AND COULD CAUSE OR CONTRIBUTE TO THE INABILITY TO DEPLOY THE DEVICE. HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED, AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. AS PER THE PRODUCT INSTRUCTIONS FOR USE: "THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE." PRIOR TO DISTRIBUTION ALL ZILVER BILIARY 635 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. 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 LOT NUMBER C1060221. IT MAY BE NOTED THAT THE FAILURE MODE OF "HANDLE FLEXOR SEPARATION - OFF LABEL USE" HAS BEEN PROVISIONALLY ASSIGNED. THE FINAL FAILURE MODE WILL BE CONFIRMED FOLLOWING DEVICE RETURN AND EVALUATION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) # K051124 / K163169. THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT THE DEVICE HAS BEEN RECEIVED AND A LAB EVALUATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITHIN 30 DAYS WITH THE FINAL INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) # K051124 / K163169. DEVICE EVALUATION THE ZIB6-80-12.0-40 DEVICE OF LOT NUMBER C1060221 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, THE COMPLAINT DEVICE WAS ADVANCED OVER AN UNKNOWN WIRE GUIDE. THE DEVICE WAS FLUSHED PRIOR TO USE. THE STENT WAS NOT DEPLOYED, NOR DID ANY PORTION OF THE STENT REMAIN IN THE PATIENT. IT IS NOT KNOWN IF THE PATIENT¿S ANATOMY WAS CALCIFIED OR TORTUOUS, OR IF PREDILATION WAS CONDUCTED PRIOR TO THIS OCCURRENCE. THE CUSTOMER CONFIRMED THAT THE HANDLE WAS PULLED TOWARDS THE HUB DURING DEPLOYMENT. THE CUSTOMER CONFIRMED THAT THE COMPLAINT DEVICE WAS USED IN THE ILIAC ARTERIES, AND THAT THE FLEXOR SHEATH CAME APART FROM THE HUB OF THE DELIVERY SYSTEM. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 11TH JANUARY 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED WITH THE RED SAFETY TAB IN PLACE. THE FLEXOR WAS FOUND TO BE SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. THE DEVICE WAS FLUSHED, AND A 0.035¿ DIAMETER WIRE GUIDE WAS PASSED THROUGH THE DEVICE WITHOUT ISSUE. CONGEALED BLOOD WAS OBSERVED IN THE DELIVERY SYSTEM. THE EVALUATING ENGINEERS WERE UNABLE TO RELEASE THE STENT IN THE LABORATORY EVALUATION. 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 THE USE IN A NON-INDICATED LOCATION OR A DIFFICULT PATIENT ANATOMY. THE CUSTOMER STATED THAT THE COMPLAINT DEVICE WAS USED IN THE ILIAC ARTERIES. AS PER THE PRODUCT INSTRUCTIONS FOR USE, "THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE". IT IS NOT KNOWN IF THE PATIENT'S ANATOMY WAS CALCIFIED OR TORTUOUS, BUT A DIFFICULT ANATOMY AND THE OFF-LABEL USE COULD CREATE RESISTANCE DURING DEPLOYMENT, AND COULD CAUSE OR CONTRIBUTE 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. IT MAY BE NOTED THAT A PROJECT HAS BEEN INITIATED TO PREVENT THE REOCCURRENCE OF THE FLEXOR SEPARATING FROM THE HANDLE. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER BILIARY (B)(4) 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 NO RISK (CATEGORY III). 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 · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT THE DEVICE HAS BEEN RECEIVED AND A LAB EVALUATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITHIN 30 DAYS WITH THE FINAL INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: THE STENT WOULD NOT DEPLOY. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER STENT.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT THE DEVICE HAS BEEN RECEIVED AND A LAB EVALUATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITHIN 30 DAYS WITH THE FINAL INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: THE STENT WOULD NOT DEPLOY. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER STENT.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION WITH THE DEVICE EVALUATION INITIAL REPORT DETAILS: THE STENT WOULD NOT DEPLOY. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888743 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G36229 10827002362298

    Patients

    Seq Age Sex Outcome Treatment
    1