BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 7726515 · Received July 27, 2018

    Report

    Report Number
    3001845648-2018-00352
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Date of Event
    July 3, 2018
    Report Date
    July 27, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002384832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # : PI00022/S014. 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 IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # : PI00022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT AS REPORTED TO CUSTOMER RELATIONS: "DEVICE WOULDN'T DEPLOY AT ALL, THE THUMB WHEEL WAS GETTING STUCK (WOULDN'T ROTATE). PULLED OUT OF PATIENT, USED ANOTHER PTX DEVICE SUCCESSFULLY (ENDED UP USING 2 STENTS INSTEAD OF 3, FUNCTIONAL BUT NOT IDEAL).¿ DEVICE EVALUATION THE ZISV6-35-125-6-140-PTX DEVICE OF LOT NUMBER C1463490 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, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A TERUMO WIRE GUIDE OF 0.035" DIAMETER. THE DEVICE WAS ADVANCED OVER A CONTRALATERAL APPROACH, AND THE AORTIC BIFURCATION WAS NOT STEEP OR TIGHT. THE CUSTOMER CONFIRMED THAT THE COMPLAINT DEVICE WAS NOT TWISTED OR ROTATED DURING ADVANCEMENT OR DEPLOYMENT. THE DEVICE WAS FLUSHED PRIOR TO USE. THE STENT WAS NOT DEPLOYED IN THE PATIENT. THE PATIENT¿S ANATOMY WAS CALCIFIED. PRE-DILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE (B)(6)2018. ON EVALUATION OF THE RETURNED DEVICE, THE FOLLOWING WAS NOTED DEFECTS: ¿ CRINKLES ON THE DISTAL STENT RETRACTION SHEATH (SRS). ¿ KINKS IN THE SRS, 38.5CM AND 53.5CM FROM THE DISTAL END OF THE SRS. ¿ STABILITY SHEATH DAMAGED JUST DISTAL TO THE OVERMOULD COMPONENT INSIDE THE DEVICE HANDLE. FUNCTIONALITY: ¿ FLUSHED WITH NO ISSUES. ¿ WIRED IN LAB WITHOUT RESISTANCE. ¿ THUMBWHEEL COULD NOT BE ROTATED IN THE LAB. ADDITIONAL FINDINGS: ¿ DEVICE RETURNED WITH THE SAFETY TRIGGER DEPRESSED, AND STENT STILL LOADED INTO THE DELIVERY SYSTEM. ¿ STENT RETRACTION WIRE WAS STILL CONNECTED TO THE STENT RETRACTION SHEATH. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THUMBWHEEL COULD NOT BE ROTATED IN THE LABORATORY. DAMAGE TO THE STABILITY SHEATH INSIDE THE HANDLE PREVENTED STENT DEPLOYMENT. POSSIBLE CAUSES FOR THIS DAMAGE COULD INCLUDE THE CALCIFIED PATIENT ANATOMY. THE DIFFICULT ANATOMY COULD HAVE CREATED RESISTANCE DURING ADVANCEMENT OR DEPLOYMENT, WHICH COULD HAVE DAMAGED THE STABILITY SHEATH. IT CAN BE NOTED THAT DURING THE EVALUATION OF THE DEVICE, ENGINEERING DETERMINED THAT THIS DAMAGE COULD HAVE OCCURRED IF THE DEVICE WAS ROTATED OR TWISTED DURING ADVANCEMENT OR DEPLOYMENT. HOWEVER, AS STATED PREVIOUSLY, THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT ROTATED OR TWISTED. THE DAMAGE ON THE STABILITY SHEATH COULD HAVE CAUSED THE SHEATH AND THE PROXIMAL INNER TO COMPRESS AND BIND TO THE STENT RETRACTION WIRE, WHICH COULD CAUSE OR CONTRIBUTE TO THE DEPLOYMENT MECHANISM MALFUNCTIONING. THE PRODUCTION SUPERVISOR WAS CONTACTED TO ASSESS THE DAMAGE ON THE STABILITY SHEATH, DISTAL TO THE OVER MOULD. THE SUPERVISOR DETERMINED THAT IF THIS DAMAGE HAD OCCURRED DURING MANUFACTURING, IT WOULD HAVE BEEN DETECTED DURING IN-LINE INSPECTION CHECKS . THEREFORE, IT IS UNLIKELY THE DEVICE COULD HAVE LEFT COOK IRELAND WITH THE DAMAGED STABILITY SHEATH. BASED ON THE ABOVE INFORMATION, AND 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 INSTRUCTIONS FOR USE (IFU0118-3). DOCUMENT REVIEW 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 C1463490. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THUMBWHEEL COULD NOT BE ROTATED IN THE LABORATORY. THE RISK WAS DETERMINED TO BE LOW (CATEGORY III). 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

    REPORT IS BEING SUBMITTED UNDER THE PRECEDENCE FOR "THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT". DEVICE WOULDN'T DEPLOY AT ALL, THE THUMB WHEEL WAS GETTING STUCK (WOULDN'T ROTATE). PULLED OUT OF PATIENT, USED ANOTHER PTX DEVICE SUCCESSFULLY (ENDED UP USING 2 STENTS INSTEAD OF 3, FUNCTIONAL BUT NOT IDEAL).

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA OF THE CONCLUSIONS OF THIS INVESTIGATION INITIAL DETAILS REPORTED: REPORT IS BEING SUBMITTED UNDER THE PRECEDENCE FOR "THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT". "DEVICE WOULDN'T DEPLOY AT ALL, THE THUMB WHEEL WAS GETTING STUCK (WOULDN'T ROTATE). PULLED OUT OF PATIENT, USED ANOTHER PTX DEVICE SUCCESSFULLY (ENDED UP USING 2 STENTS INSTEAD OF 3, FUNCTIONAL BUT NOT IDEAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568917 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD G38483 C1463490 10827002384832

    Patients

    Seq Age Sex Outcome Treatment
    1