BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 3905080 · Received May 22, 2014

    Report

    Report Number
    3001845648-2014-00085
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 24, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION CONDUCTED ON (B)(4) 2014 CONFIRMED THE STENT WAS FRACTURED. THIS WAS NOT MENTIONED BY INITIAL REPORTER. BASED ON THE LAB EVALUATION, THIS COMPLAINT EVENT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR STENT BREAKAGES; REGARDLESS OF PATIENT OUTCOME. ADDITIONAL INFORMATION: THERE WERE NO ZIV6-35-125-7-80-PTX (ZILVER PTX) DEVICES OF LOT NUMBER C962907 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 1 X ZIV6-35-125-7-80-PTX DEVICE OF JOT NUMBER C962907 WAS RETURNED FOR EVALUATION. DEVICE WAS RETURNED IN THE ORIGINAL OUTER BOX AND WAS OPEN ON RECEIPT. ON EVALUATION OF THE RETURNED DEVICE IT WAS EVIDENT THAT DISTAL PART OF THE STENT WAS EXITING THE OUTER SHEATH. USING CALIBRATED RULER THE EXPOSED PART OF THE STENT MEASURED APPROX. 11MM. FURTHER EXAMINATION OF THE EXPOSED PART REVEALED MISSING GOLD RIVETS AND THEREFORE DISTAL PART OF THE STENT WAS CONFIRMED TO BE FRACTURED AND MISSING. THE FRACTURED PIECE OF THE STENT WAS NOT RETURNED FOR EVALUATION. COMPLAINT ORIGINATOR WAS NOTIFIED ABOUT THE MISSING STENT PORTION. USING CALIBRATED RULER THE OUTER SHEATH MEASURED 126.6 CM AND WAS NOTED TO BE ELONGATED. THE ENTIRE DELIVERY SYSTEM HAS BEEN EXAMINED FOR DAMAGE AND NO TACTILE DAMAGE COULD BE DETECTED. USING 1ML SYRINGE WITH WATER THE DEVICE WAS FLUSHED THROUGH THE HANDLE PORT AND THROUGH THE SIDE PORT WITHOUT DIFFICULTIES. LARGE AMOUNT OF BLOOD CAME OUT FROM THE DELIVERY SYSTEM. THE DEVICE WAS ADVANCED OVER THE NON HYDROPHILIC 0.035" WIRE GUIDE HOWEVER RESISTANCE WAS ENCOUNTERED POSSIBLY DUE TO CONGEALED BLOOD INSIDE THE LUMEN OF THE INNER CATHETER. DURING LABORATORY EVALUATION THE STENT WAS FULLY DEPLOYED WITHOUT RESISTANCE. UPON STENT DEPLOYMENT IT WAS EVIDENT THAT MIDDLE PART OF THE STENT WAS STRETCHED. DISTAL END OF THE PEEK TUBING WAS EXAMINED USING THE MICROSCOPE. NO DAMAGE OR INDENTATION WAS EVIDENT ON THE EDGE OF THE PUSHER RING. NO EXCESS GLUE AND NO DAMAGE TO THE INNER CATHETER WAS OBSERVED PROXIMALLY OR DISTALLY TO THE PUSHER RING. FLEXOR COILS AT THE DISTAL AND PROXIMAL PART OF THE OUTER SHEATH WERE EXAMINED USING THE MICROSCOPE. DISTANCE BETWEEN FLEXOR COILS WAS CONFIRMED TO BE UNIFORM ALONG THE SHEATH LENGTH WHICH INDICATED THAT DISTAL PART OF THE SHEATH (IN THE REGION OF ELONGATED STENT) WAS NOT STRETCHED. THE STENT'S STRUTS RETURNED TO ITS REQUIRED SHAPE AND STENT DEFORMATION WAS NO LONGER EVIDENT. USING CALIBRATED RULER THE STENT MEASURED APPROX. 75MM CONFIRMING THAT APPROX. 5MM OF THE STENT WAS MISSING. CLARIFICATION ON THE STATEMENT 'DISTAL END OF THE STENT DID NOT LOOK RIGHT' WAS REQUESTED. PROVIDED INFORMATION REVEALED THAT "THE STENT APPEARED KINKED, PINCHED ON ITSELF OR NOT UNIFORM". IT IS POSSIBLE THAT THE STENT WAS NOT EXPANDING PROPERLY AND COULD HAVE 'APPEARED KINKED' DUE TO CALCIFIED LESION AS THE ZILVER PTX DEVICE WAS BEING PLACED IN A HEAVILY CALCIFIED SEGMENT. IT MAY BE NOTED HOWEVER THAT ACCORDING TO THE CUSTOMER COMPLAINT FORM, IMAGES, X-RAYS OR SCANS WILL NOT BE PROVIDED THEREFORE STENT APPEARANCE DURING DEPLOYMENT CANNOT BE VERIFIED. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ALSO REVEALED THAT THE STENT WAS DEPLOYED ABOUT 1CM AND NO RESISTANCE WAS NOTED DURING DEVICE REMOVAL. DEVICE WAS REMOVED IN CONTROLLED MANNER AND WITHOUT ALLOWING MORE STENT TO BE DEPLOYED. THE SHEATH (RAABE) WAS ADVANCED OVER THE "KINKED STENT" AND WHEN IT WAS BELIEVED TO BE CAPTURED, IT WAS THEN REMOVED UNDER CONSTANT FLURO, WHILE PHYSICIAN HELD THE METAL CANNULA AND MAIN BODY OF PLASTIC (DISTAL TO THE METAL CANNULA); ALL WHILE THE FELLOW WAS STABILIZING THE SHEATH. IT MAY BE ALSO NOTED THAT THE SALES REP WILL FOLLOW UP WITH THE PHYSICIAN IN REGARDS TO THE FRACTURED AND MISSING PORTION OF THE STENT UPON EVALUATION OF THE RETURNED DEVICE, THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS THE STENT WAS NOT DEPLOYED DURING THE PROCEDURE. MOREOVER, DISTAL PART OF THE STENT WAS FOUND TO BE FRACTURED AND MISSING. A CAUSE OF THE STENT FRACTURE IN THIS OCCURRENCE MAY BE ATTRIBUTED TO THE USER TECHNIQUE DURING THE PROCEDURE. ADDITIONAL INFORMATION CONFIRMED THAT THE GUIDING SHEATH WAS ADVANCED OVER THE PARTIALLY DEPLOYED STENT. STENT SEPARATION MORE LIKELY OCCURRED AT THIS STAGE AS THE STENT IS NOT DESIGNED FOR REPOSITIONING OR RECAPTURING (AS INDICATED IN THE ZILVER PTX INSTRUCTION FOR USE). EVIDENCE OF STENT STRETCHING OBSERVED DURING LABORATORY EVALUATION ALSO INDICATED THAT THE USER ATTEMPTED RE-ADVANCE THE SHEATH OVER THE STENT. THE SHEATH WAS PUSHED AGAINST THE STENT WHICH CAUSED THE ELONGATION OF THE MIDDLE PART OF THE STENT. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN THE LABORATORY SETTINGS A DEFINITIVE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. PRODUCTION SUPERVISOR AND FQC SUPERVISOR WERE NOTIFIED ABOUT THE INVESTIGATION FINDINGS. IT MAY BE NOTED THAT THE FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTION FOR USE: "...CARE SHOULD BE TAKEN WHEN DEPLOYING THE STENT TO MINIMIZE THE RISK OF STENT FRACTURE DUE TO ELONGATION AT IMPLANT" 'THE STENT IS NOT DESIGNED FOR REPOSITIONING OR RECAPTURING" "ONCE STENT DEPLOYMENT HAS BEGUN, THE STENT MUST BE FULLY DEPLOYED. REPOSITIONING OF THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT IS NOT POSSIBLE SINCE THE DELIVERY SYSTEM'S OUTER SHEATH CANNOT BE RE-ADVANCED OVER THE STENT ONCE DEPLOYMENT BEGINS". 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 FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ANOTHER DEVICE OF THE SAME JOT NUMBER WAS USED INSTEAD AND ACCORDING TO THE INITIAL REPORTER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING ASSESSED THE COMPLAINT AND THE RISK HAS BEEN DETERMINED TO BE MODERATE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    A ZILVER PTX STENT WAS BEING PLACED POST ARTHRECTOMY IN A HEAVILY CALCIFIED SEGMENT. AS THE STENT WAS BEING DEPLOYED, THE PHYSICIAN NOTICED THE STENT WAS NOT EXPANDING PROPERLY AND UNDER INTENSE MAGNIFICATION NOTICED THE DISTAL END OF THE STENT DID NOT LOOK RIGHT. THE STENT WAS REMOVED WITH MINIMAL DIFFICULTY AS THERE WAS MINIMAL AMOUNT OF STENT EXPOSED. A DIFFERENT ZILVER PTX STENT WITH THE SAME LOT NUMBER WAS IMPLANTED WITHOUT ANY ISSUES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307047 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C962907

    Patients

    Seq Age Sex Outcome Treatment
    1 NP