BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 6813461 · Received August 23, 2017

    Report

    Report Number
    3001845648-2017-00355
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    June 21, 2017
    Report Date
    August 23, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002384825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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)#: P100022/S014 THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY. THE PHYSICIAN ADVANCED OVER THE WIRE, STENT DEPLOYED AS EXPECTED. WHEN TRYING TO REMOVE THE DEVICE BACK OUT IT WOULD NOT TRACK BACK OVER THE WIRE. THE PHYSICIAN HAD TO CUT THE CATHETER BUT WAS NOT ABLE TO CUT ALL THE WAY THROUGH DUE TO THE METAL COILING INSIDE THE CATHETER. PHYSICIAN THEN BROKE THE HANDLE TO WORK THE DEVICE OUT HOWEVER THIS STILL DID NOT WORK. PHYSICIAN KEPT WORKING WITH THE SYSTEM TRYING TO WORK IT OUT. THERE WAS A TIGHT SPOT NOTED WHILE REMOVING THE DEVICE AND ONCE PASSED THAT SPOT THE DEVICE CAME OUT FINE. THE DISTRICT MANAGER CONFIRMED THAT OTHER DEVICES HAD BEEN USED OVER THE WIRE; CXI CATHETER, DAVIS CATHETER, UB3 BALLOON. ALL OTHER DEVICES TRACKED FINE WITHOUT ANY ISSUES. IT WAS ALSO CONFIRMED THAT THE PHYSICIAN SWITCHED BACK AND FORTH WITH THIS NON-HYDROPHILIC WIRE AND A HYDROPHILIC WIRE DURING THE PROCEDURE AND ONLY HAD DIFFICULTY WITH THE NON- HYDROPHILIC WIRE AND REMOVING THE DEVICE. THERE WAS NO HARM TO THE PATIENT JUST THE PROCEDURE TOOK A FEW MINUTES LONGER WHILE TRYING TO GET THE DEVICE REMOVED AS THE PHYSICIAN WAS TAKING IT SLOW AND CAUTIOUS."

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K)#: P100022/S014. THE ZISV6-35-125-6-120-PTX DEVICE OF LOT NUMBER C1348872 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. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A 0.035¿ DIAMETER NON-HYDROPHILIC WIRE GUIDE, POSSIBLY A COOK BENTSON. THE WIRE GUIDE WAS USED PRIOR TO THIS INCIDENT. THE PHYSICIAN NOTED THAT UPON TAKING THE DEVICE AND WIRE OUT, THE WIRE LOOKED SEVERELY KINKED AFTER NAVIGATING THROUGH TORTUOUS ANATOMY. THE DEVICE WAS FLUSHED AS PER THE IFU. THE PROCEDURE, FROM ADVANCEMENT TO THE ATTEMPTED REMOVAL OF THE DEVICE, WAS TWO TO THREE HOURS. THE PATIENT ANATOMY WAS SEVERELY CALCIFIED AND TORTUOUS. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE COMPLAINT DEVICE TO THE TARGET LOCATION. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE WIRE GUIDE WAS RETURNED WITH THE DEVICE AND WAS MEASURED AS 0.035¿ DIAMETER. THE WIRE GUIDE WAS SEVERELY KINKED. THE DEVICE WAS FLUSHED WITHOUT ISSUES, AND A NEW 0.035¿DIAMETER WIRE GUIDE WAS PASSED THROUGH THE DEVICE WITHOUT RESISTANCE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. POSSIBLE CAUSE COULD INCLUDE THE SEVERELY CALCIFIED AND TORTUOUS ANATOMY. THE PHYSICIAN STATED THAT THE WIRE GUIDE WAS SEVERELY KINKED, POSSIBLY FROM THE PATIENT ANATOMY. THE KINK IN THE WIRE GUIDE COULD HAVE PREVENTED THE WIRE GUIDE FROM MOVING SMOOTHLY THROUGH THE DEVICE LUMEN. THIS FACTOR COULD HAVE CAUSED OR CONTRIBUTED TO THE INABILITY TO WITHDRAW THE DEVICE OVER THE WIRE GUIDE. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. FROM THE PRODUCT INSTRUCTION FOR USE: ¿FOLLOWING STENT DEPLOYMENT, IF RESISTANCE IS MET DURING THE WITHDRAWAL OF THE DELIVERY SYSTEM, CAREFULLY REMOVE THE DELIVERY SYSTEM AND WIRE GUIDE AS A UNIT¿. PRIOR TO DISTRIBUTION ALL ZILVER PTX 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 C1348872. 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 · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY. THE PHYSICIAN ADVANCED OVER THE WIRE, STENT DEPLOYED AS EXPECTED. WHEN TRYING TO REMOVE THE DEVICE BACK OUT IT WOULD NOT TRACK BACK OVER THE WIRE. THE PHYSICIAN HAD TO CUT THE CATHETER BUT WAS NOT ABLE TO CUT ALL THE WAY THROUGH DUE TO THE METAL COILING INSIDE THE CATHETER. PHYSICIAN THEN BROKE THE HANDLE TO WORK THE DEVICE OUT HOWEVER THIS STILL DID NOT WORK. PHYSICIAN KEPT WORKING WITH THE SYSTEM TRYING TO WORK IT OUT. THERE WAS A TIGHT SPOT NOTED WHILE REMOVING THE DEVICE AND ONCE PASSED THAT SPOT THE DEVICE CAME OUT FINE. THE DISTRICT MANAGER CONFIRMED THAT OTHER DEVICES HAD BEEN USED OVER THE WIRE; CXI CATHETER, DAVIS CATHETER, UB3 BALLOON. ALL OTHER DEVICES TRACKED FINE WITHOUT ANY ISSUES. IT WAS ALSO CONFIRMED THAT THE PHYSICIAN SWITCHED BACK AND FORTH WITH THIS NON-HYDROPHILIC WIRE AND A HYDROPHILIC WIRE DURING THE PROCEDURE AND ONLY HAD DIFFICULTY WITH THE NON- HYDROPHILIC WIRE AND REMOVING THE DEVICE. THERE WAS NO HARM TO THE PATIENT JUST THE PROCEDURE TOOK A FEW MINUTES LONGER WHILE TRYING TO GET THE DEVICE REMOVED AS THE PHYSICIAN WAS TAKING IT SLOW AND CAUTIOUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594335 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD G38482 10827002384825

    Patients

    Seq Age Sex Outcome Treatment
    1