BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 7590740 · Received June 12, 2018

    Report

    Report Number
    3001845648-2018-00262
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 18, 2018
    Report Date
    June 12, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002438573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #P050017/S002 AND S003. 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. INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #P050017/S002 AND S003. 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)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT: AS REPORTED TO CUSTOMER RELATIONS: "STENT FAILED TO DEPLOY. ON SECOND DEVICE ATTEMPT (G43857, FROM LOT # C1354628), SAME DIFFICULTIES OCCURRED BUT THE PHYSICIAN WAS STILL ABLE TO ULTIMATELY DEPLOY THE STENT. STENT OUTER CATHETER DETACHED FROM THE HUB. MANAGED TO HOLD ONE OF THEM BY HOLDING BLUE OUTER CATHETER TO THE HUB. RETRIEVED SYSTEM OF 2ND DEVICE AS WELL, AND BOTH SYSTEMS ARE AVAILABLE FOR RETURN." DEVICE EVALUATION: THE ZIV6-35-80-8-60 DEVICE 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. THERE ARE TWO DEVICES AND COMPLAINT FILES LINKED TO THIS OCCURRENCE. REFER TO COMPLAINT FILE (B)(4) FOR DETAILS OF THE SECOND COMPLAINT DEVICE. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A TERUMO BENSON WIRE GUIDE OF UNKNOWN DIAMETER. RESISTANCE WAS NOT ENCOUNTERED DURING DEPLOYMENT. THE DEVICE WAS USED IN THE BILIARY TREE. PRE-DILATION WAS NOT CONDUCTED PRIOR TO STENT DEPLOYMENT THE DEVICE WAS FLUSHED PRIOR TO USE. OF THE TWO DEVICES USED IN THE PROCEDURE, ONLY ONE WAS IMPLANTED IN THE PATIENT. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 14TH JUNE 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE WAS RETURNED WITH A STENT, AND THE STENT WAS ALREADY DEPLOYED. THE FLEXOR WAS FOUND TO BE SEPARATED FROM THE DEVICE HANDLE AT THE WHITE CONNECTOR CAP. THE DEVICE WAS RETURNED WITH A WIRE GUIDE STILL LOADED IN THE DEVICE LUMEN. THE WIRE GUIDE WAS 0.0345¿ DIAMETER, AND WAS UNDAMAGED. THE FLEXOR LENGTH WAS 80.5CM, WHICH WAS WITHIN SPECIFICATION OF 80CM +1.3CM -0.8CM. THE STENT WAS MEASURED AS 6CM LONG, AND WAS UNDAMAGED (REF ATT. 'IMAGES'). THE STENT WAS LATER IDENTIFIED TO BE RELATED TO THE COMPLAINT DEVICE FOR (B)(4).COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE FLEXOR WAS FOUND TO BE SEPARATED FROM THE DEVICE HANDLE AT THE WHITE CONNECTOR CAP. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE USE OF THE DEVICE IN A NON-INDICATED LOCATION. FROM CUSTOMER TESTIMONY, THE DEVICE WAS USED IN THE BILIARY TREE. THIS COULD HAVE CREATED HIGH DEPLOYMENT FORCES, AND 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. THE FOLLOWING IS STATED IN THE PRODUCT INSTRUCTION FOR USE: "THE ZILVER VASCULAR STENT IS INTENDED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES. IT MAY BE NOTED THAT PROJECT (B)(4) HAS BEEN INITIATED TO PREVENT THE REOCCURRENCE OF HANDLE/FLEXOR SEPARATION. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZILVER VASCULAR 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 DEVICE 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 · 0

    AS REPORTED TO CUSTOMER RELATIONS: "STENT FAILED TO DEPLOY. ON SECOND DEVICE ATTEMPT (G43857, FROM LOT # C1354628), SAME DIFFICULTIES OCCURRED BUT THE PHYSICIAN WAS STILL ABLE TO ULTIMATELY DEPLOY THE STENT. STENT OUTER CATHETER DETACHED FROM THE HUB. MANAGED TO HOLD ONE OF THEM BY HOLDING BLUE OUTER CATHETER TO THE HUB. RETRIEVED SYSTEM OF 2ND DEVICE AS WELL, AND BOTH SYSTEMS ARE AVAILABLE FOR RETURN."

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS AS REPORTED TO CUSTOMER RELATIONS: "STENT FAILED TO DEPLOY. ON SECOND DEVICE ATTEMPT (G43857, FROM LOT # C1354628), SAME DIFFICULTIES OCCURRED BUT THE PHYSICIAN WAS STILL ABLE TO ULTIMATELY DEPLOY THE STENT. STENT OUTER CATHETER DETACHED FROM THE HUB. MANAGED TO HOLD ONE OF THEM BY HOLDING BLUE OUTER CATHETER TO THE HUB. RETRIEVED SYSTEM OF 2ND DEVICE AS WELL, AND BOTH SYSTEMS ARE AVAILABLE FOR RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434478 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD G43857 C1354628 10827002438573

    Patients

    Seq Age Sex Outcome Treatment
    1