BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 7458341 · Received April 25, 2018

    Report

    Report Number
    3001845648-2018-00180
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    March 30, 2018
    Report Date
    April 25, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002314860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. 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: "UPON OPENING THE PACKAGE OF THE DEVICE, A KINK WAS NOTED ON THE SHEATH. THEREFORE, ANOTHER COOK'S ZILVER STENT (ANOTHER SIZE) WAS USED INSTEAD. PHYSICIAN AND SALES REP'S COMMENT:I THINK THAT THE SHEATH GOT KINKED DURING TRANSPORT." DEVICE EVALUATION: THE ZIB6-40-6.0-40 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. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 3RD MAY 2018. ON EVALUATION OF THE RETURNED DEVICE, A KINK WAS OBSERVED IN THE FLEXOR, JUST DISTAL TO WHITE CAP. IT WAS NOT POSSIBLE TO PASS A 0.035¿ DIAMETER WIRE GUIDE THROUGH THE DEVICE. THE STENT WAS DEPLOYED IN THE LAB. THE STENT WAS NOT DAMAGED, AND WAS 4CM LONG. THERE WAS EVIDENCE OF CONGEALED BLOOD ON THE STENT, SUGGESTING THE DEVICE MADE PATIENT CONTACT. THE CUSTOMER WAS CONTACTED, AND CONFIRMED THAT THE KINK WAS OBSERVED PRIOR TO PATIENT CONTACT. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. A KINK WAS OBSERVED IN THE FLEXOR, JUST DISTAL TO WHITE CAP. POSSIBLE ROOT CAUSES FOR THIS OCCURRENCE COULD INCLUDE DEVICE HANDLING WHILE INSIDE AND ON REMOVAL FROM THE PACKAGING. INCORRECT DEVICE HANDLING COULD HAVE CAUSED OR CONTRIBUTED TO THE KINK IN THE FLEXOR. 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. 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 LABORATORY. A KINK WAS OBSERVED IN THE FLEXOR, JUST DISTAL TO WHITE 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. US CLEARANCE # K040505 K163169. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. 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: "UPON OPENING THE PACKAGE OF THE DEVICE, A KINK WAS NOTED ON THE SHEATH. THEREFORE, ANOTHER COOK'S ZILVER STENT (ANOTHER SIZE) WAS USED INSTEAD. PHYSICIAN AND SALES REP'S COMMENT: I THINK THAT THE SHEATH GOT KINKED DURING TRANSPORT." DEVICE EVALUATION: THE ZIB6-40-6.0-40 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. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 3RD MAY 2018. ON EVALUATION OF THE RETURNED DEVICE, A KINK WAS OBSERVED IN THE FLEXOR, JUST DISTAL TO WHITE CAP. IT WAS NOT POSSIBLE TO PASS A 0.035¿ DIAMETER WIRE GUIDE THROUGH THE DEVICE. THE STENT WAS DEPLOYED IN THE LAB. THE STENT WAS NOT DAMAGED, AND WAS 4CM LONG. THERE WAS EVIDENCE OF CONGEALED BLOOD ON THE STENT, SUGGESTING THE DEVICE MADE PATIENT CONTACT. THE CUSTOMER WAS CONTACTED, AND CONFIRMED THAT THE KINK WAS OBSERVED PRIOR TO PATIENT CONTACT. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. A KINK WAS OBSERVED IN THE FLEXOR, JUST DISTAL TO WHITE CAP. POSSIBLE ROOT CAUSES FOR THIS OCCURRENCE COULD INCLUDE DEVICE HANDLING WHILE INSIDE AND ON REMOVAL FROM THE PACKAGING. INCORRECT DEVICE HANDLING COULD HAVE CAUSED OR CONTRIBUTED TO THE KINK IN THE FLEXOR. 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. 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 LABORATORY. A KINK WAS OBSERVED IN THE FLEXOR, JUST DISTAL TO WHITE 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.

    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. 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.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS. UPON OPENING THE PACKAGE OF THE DEVICE, A KINK WAS NOTED ON THE SHEATH. THEREFORE, ANOTHER COOK'S ZILVER STENT (ANOTHER SIZE) WAS USED INSTEAD.

    Description of Event or Problem · 0

    UPON OPENING THE PACKAGE OF THE DEVICE, A KINK WAS NOTED ON THE SHEATH. THEREFORE, ANOTHER COOK'S ZILVER STENT (ANOTHER SIZE) WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305299 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002314860

    Patients

    Seq Age Sex Outcome Treatment
    1