BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 6484626 · Received April 12, 2017

    Report

    Report Number
    3001845648-2017-00124
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    January 23, 2017
    Report Date
    April 12, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002352831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/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. 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

    PMA/510(K) # P100022/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. THE ZISV6-35-125-6.0-80-PTX DEVICE OF LOT C1242630 RELATED TO THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ON EVALUATION OF THE RETURNED DEVICE, INTERMITTENT CRIMPLING DAMAGE WAS OBSERVED ON THE OUTER SHEATH OVER A 10CM LENGTH FROM THE END OF THE STABILITY SHEATH. APART FROM THE CRIMPLED PORTION, THERE WAS NO EVIDENCE OF KINKING DAMAGE ON THE DELIVERY SYSTEM. THE STABILITY SHEATH WAS MEASURED AS 0.725¿ DIAMETER AT A NON-DAMAGED LOCATION. THE CRIMPLED PORTION OF THE STABILITY SHEATH WAS MEASURED BETWEEN 0.735¿ AND 0.79¿ DIAMETER. THE CRIMPLING DAMAGE COULD HAVE BEEN CAUSED BY A TIGHT RADIUS, SUCH AS THE BIFURCATION ANGLE. THE DEVICE WAS FLUSHED WITH DIFFICULTY, POSSIBLY DUE TO THE CONGEALED BLOOD. THE DEVICE WAS WIRED WITH A 0.035¿ DIAMETER WIRE GUIDE WITH MINOR DIFFICULTY DUE TO THE CONGEALED BLOOD. A SECOND ATTEMPT TO WIRE THE DEVICE SUCCEEDED WITHOUT ISSUES. THE SAFETY TRIGGER WAS DEPRESSED AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT. THE THUMBWHEEL ROTATED BUT THE STENT DID NOT DEPLOY. THE ENGINEERS OPENED THE HANDLE, AND OBSERVED THAT THE STENT RETRACTION WIRE WAS SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). THE CUSTOMER COMPLAINT IS CONFIRMED AS THE DEVICE OUTER SHEATH WAS CRIMPLED. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PATIENT ANATOMY. THE PATIENT ANATOMY COULD HAVE LED TO THE CRIMPLING IN THE OUTER SHEATH. IT MAY BE NOTED, HOWEVER, THAT THE PATIENT ANATOMY WAS DESCRIBED AS SUITABLE FOR THE PROCEDURE. THE CRIMPLING DAMAGE COULD HAVE CAUSED OR CONTRIBUTED TO THE RESISTANCE ENCOUNTERED DURING ADVANCEMENT. IN ADDITION, THE DIFFICULT PATIENT ANATOMY COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT RETRACTION WIRE SEPARATING FROM THE SRS DURING ADVANCEMENT. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. AS PER THE PRODUCT INSERT: ¿WHEN EXCESSIVE RESISTANCE IS FELT DURING INSERTION OF THE DELIVERY SYSTEM, DO NOT CONTINUE THE OPERATION FORCIBLY. THE OPERATION SHOULD BE INTERRUPTED TO REMOVE THE DELIVERY SYSTEM AND REPLACE IT WITH A NEW DEVICE.¿ PRIOR TO DISTRIBUTION, ALL ZISV6 (ZILVER PTX) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THIS INCLUDES A 100% VISUAL INSPECTION OF OUTER SHEATH. ANY PROBLEMS WITH THE SHEATH WOULD HAVE BEEN DISCOVERED AT THIS POINT A REVIEW OF THE OTHER 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 AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1242630. ACCORDING TO INFORMATION PROVIDED, 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

    THE DEVICE WAS ADVANCED FROM RIGHT FA TO THE LESION OF SFA CONTRALATERALLY TO PERFORM PTA. THE PATIENT'S ANATOMICAL FORM WERE SUITABLE FOR THE PROCEDURE. FIRST, GUIDING SHEATH WAS ADVANCED ((B)(4), DESTINATION 6FR). THEN, THE PHYSICIAN ATTEMPTED TO ADVANCE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT OVER THE WIRE GUIDE ((B)(4)/RADIFOCUS 0.035), HOWEVER, THE DEVICE GOT CAUGHT IN THE MIDDLE OF ADVANCEMENT. SINCE HE FELT THE SAME FEELING LIKE IT GOT CAUGHT EVEN HE TRIED SEVERAL TIMES, HE STOPPED USING THE COMPLAINT DEVICE. ALSO IT WAS SUSPECTED KINK IN THE DELIVERY SYSTEM. IT WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE WITHOUT PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT REPORTED. THE DEVICE RELATED TO THIS COMPLAINT WAS EVALUATED.. THE ENGINEERS DETERMINED THAT THE FAILURE MODE WAS: ''RETRACTION WIRE SEPARATES FROM RETRACTION SHEATH'. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'RETRACTION WIRE SEPARATES FROM RETRACTION SHEATH'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THE DEVICE WAS ADVANCED FROM RIGHT FA TO THE LESION OF SFA CONTRALATERALLY TO PERFORM PTA. THE PATIENT'S ANATOMICAL FORM WERE SUITABLE FOR THE PROCEDURE. FIRST, GUIDING SHEATH WAS ADVANCED (TERUMO, DESTINATION 6FR). THEN, THE PHYSICIAN ATTEMPTED TO ADVANCE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT OVER THE WIRE GUIDE (TERUMO/RADIFOCUS 0.035), HOWEVER, THE DEVICE GOT CAUGHT IN THE MIDDLE OF ADVANCEMENT. SINCE HE FELT THE SAME FEELING LIKE IT GOT CAUGHT EVEN HE TRIED SEVERAL TIMES, HE STOPPED USING THE COMPLAINT DEVICE. ALSO IT WAS SUSPECTED KINK IN THE DELIVERY SYSTEM. IT WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE WITHOUT PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT REPORTED. THE DEVICE RELATED TO THIS COMPLAINT WAS EVALUATED. THE ENGINEERS DETERMINED THAT THE FAILURE MODE WAS: ''RETRACTION WIRE SEPARATES FROM RETRACTION SHEATH'. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'RETRACTION WIRE SEPARATES FROM RETRACTION SHEATH'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266469 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002352831

    Patients

    Seq Age Sex Outcome Treatment
    1