BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 6481038 · Received April 11, 2017

    Report

    Report Number
    3001845648-2017-00123
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    February 3, 2017
    Report Date
    April 11, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002362397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) # K163169. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.

    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) # K163169. THE ZIB6-125-12.0-40 DEVICE OF LOT C1291451 WAS RETURNED FOR EVALUATION, IN THE OPEN, ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM INFORMATION PROVIDED BY THE CUSTOMER, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A 0.035¿ DIAMETER WIRE GUIDE. THE DEVICE WAS FLUSHED PRIOR TO USE, AS PER THE IFU. THE PATIENT ANATOMY WAS CALCIFIED AT THE ILIAC BIFURCATION. THE CUSTOMER DOES NOT KNOW IF PRE-DILATION WAS CONDUCTED PRIOR TO THE OCCURRENCE. THE CUSTOMER CONFIRMED THAT THE HANDLE WAS PULLED TOWARDS THE HUB DURING DEPLOYMENT. THE STENT WAS NOT DEPLOYED IN THE PATIENT. THE CUSTOMER REPORTED THAT THE TARGET LOCATION FOR THE COMPLAINT DEVICE WAS THE COMMON ILIAC ARTERY. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE OUTER FLEXOR HAD PULLED FROM THE HANDLE AT THE WHITE HUB. THERE WAS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT DEVICE WAS MANUFACTURED INCORRECTLY. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE OUTER SHEATH WAS PULLED FROM THE HANDLE. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PATIENT ANATOMY, AND THE USE OF THE DEVICE IN A NON-INDICATED LOCATION. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE TARGET LOCATION WAS IN THE COMMON ILIAC ARTERY, AND THAT THE PATIENT¿S ILIAC BIFURCATION WAS CALCIFIED. THE PHYSICIAN ALSO REPORTED THAT EXTREME RESISTANCE WAS ENCOUNTERED DURING THE ATTEMPTED DEPLOYMENT. THE DIFFICULT ANATOMY COULD HAVE CREATED THE RESISTANCE ENCOUNTERED DURING DEPLOYMENT, AND LEAD TO HIGH DEPLOYMENT FORCES. THE HIGH DEPLOYMENT FORCES COULD HAVE CAUSED OR CONTRIBUTED TO THE OUTER FLEXOR PULLING FROM THE HANDLE. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. IT MAY BE NOTED THAT AS PER THE PRODUCT IFU: ¿THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE.¿ PRIOR TO DISTRIBUTION, ALL ZIB6 (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 C1291451. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER ADVANCED THE DELIVERY SHEATH INTO BODY WITH STENT AND IT WAS A CALCIFIED BIFURCATION. NO TROUBLE ADVANCING SYSTEM INTO THE BODY. THEY PULLED THE RED SAFETY AND BEGAN TO PIN AND PULL THE STENT DEPLOYMENT SYSTEM. THERE WAS EXTREME RESISTANCE WHEN TRYING TO PULL BACK ON THE SYSTEM. THEY PULLED HARD ENOUGH AND THE HUB SNAPPED BACK AND THE STENT DID NOT DEPLOY. THEY TOOK THE DEPLOYMENT SYSTEM OUT OF THE BODY. THEY BELIEVED THE STENT EITHER GOT STUCK ON SHEATH OR WHEN TAKING OFF THE RED SAFETY, THE SAFETY MAY NOT HAVE UNLOCKED. THE PHYSICIAN CONSIDERED THE CASE DONE AND THE PATIENT DID NOT RECEIVE THE STENT. THE DEVICE RELATED TO THIS COMPLAINT WAS EVALUATED IN THE LAB. THE ENGINEERS DETERMINED THAT THE FAILURE MODE WAS: "HANDLE/FLEXOR SEPARATION". EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'FLEXOR BREAKAGE DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    THIS FOLLOW UP IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION DETAILS. IT WAS REPORTED THAT THE USER ADVANCED THE DELIVERY SHEATH INTO BODY WITH STENT AND IT WAS A CALCIFIED BIFURCATION. NO TROUBLE ADVANCING SYSTEM INTO THE BODY. THEY PULLED THE RED SAFETY AND BEGAN TO PIN AND PULL THE STENT DEPLOYMENT SYSTEM. THERE WAS EXTREME RESISTANCE WHEN TRYING TO PULL BACK ON THE SYSTEM. THEY PULLED HARD ENOUGH AND THE HUB SNAPPED BACK AND THE STENT DID NOT DEPLOY. THEY TOOK THE DEPLOYMENT SYSTEM OUT OF THE BODY. THEY BELIEVED THE STENT EITHER GOT STUCK ON SHEATH OR WHEN TAKING OFF THE RED SAFETY, THE SAFETY MAY NOT HAVE UNLOCKED. THE PHYSICIAN CONSIDERED THE CASE DONE AND THE PATIENT DID NOT RECEIVE THE STENT. THE DEVICE RELATED TO THIS COMPLAINT WAS EVALUATED IN THE LAB. THE ENGINEERS DETERMINED THAT THE FAILURE MODE WAS: "HANDLE/FLEXOR SEPARATION". EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'FLEXOR BREAKAGE DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262962 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002362397

    Patients

    Seq Age Sex Outcome Treatment
    1