BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX 35 DRUG/ELUTING STENT

    MDR report key: 4190147 · Received October 17, 2014

    Report

    Report Number
    3001845648-2014-00189
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: P100022 AND S001. INCIDENT MEETS THE REQUIREMENT OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY FOR 'STENT SHORTENING' REGARDLESS OF PT OUTCOME. (B)(4) DEVICE OF LOT NUMBER C992429 WAS RETURNED TO FOR EVALUATION. DEVICE WAS RETURNED IN THE ORIGINAL PACKAGE AND WAS OPEN ON RECEIPT. ON EVALUATION OF THE RETURNED DEVICE IT HAS BEEN CONFIRMED THAT THE STENT HAD BEEN DEPLOYED AND ONLY THE DELIVERY SYS WAS RETURNED FOR EVALUATION. THE ENTIRE DELIVERY SYS HAS BEEN EXAMINED FOR DAMAGE AND THERE WAS NO EVIDENCE OF DAMAGE. THE OUTER SHEATH WAS MEASURED AND NOTED TO BE AS PER SPECIFICATION. USING 1 ML SYRINGE WITH WATER, DEVICE WAS FLUSHED THROUGH THE FLUSHING PORTS - NO ISSUES NOTED. DELIVERY SYS WAS ADVANCED OVER THE NON HYDROPHILIC 0.035" WIRE GUIDE WITHOUT ANY DIFFICULTIES. DISTAL END OF THE INNER CATHETER WAS VISUALLY EXAMINED. NO EXCESS GLUE AND NO DAMAGE OR INDENTATION WAS EVIDENT ON THE EDGE OF THE PUSHER RING. FROM THE EXAMINATION OF THE RETURNED DEVICE, THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE COULD HAVE MALFUNCTIONED AND CONTRIBUTED TO THE REPORTED STENT COMPRESSION. TWO STILL IMAGES SHOWING THE STENT PORT DEPLOYMENT WERE PROVIDED. BASED ON THE IMAGES PROVIDED, THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE STENT APPEARED TO BE SHORTENED/COMPRESSED. IT CAN BE NOTED THAT NO DEFECT WAS DETECTED DURING EVALUATION OF THE RETURNED DEVICE. UPON EVALUATION OF THE RETURNED DEVICE AND FROM THE COMPLAINT INFO PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER EXPERIENCED DIFFICULTY DURING STENT DEPLOYMENT, WHICH COULD HAVE RESULTED IN STENT COMPRESSION. THE MOST LIKELY CAUSE OF THIS EVENT CAN BE ATTRIBUTED TO THE USER ERROR. THE USER PROBABLY HAD SLACK IN THE SYS AND MORE THAN LIKELY PUSHED THE PIN FORWARD WHICH RESULTED IN STENT COMPRESSION. HOWEVER, AS THE CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LAB SETTINGS, A DEFINITIVE ROOT CAUSE OF THIS STENT COMPRESSION CANNOT BE DETERMINED. IT MAY BE NOTED THAT THE FOLLOWING INFO IS INCLUDED IN INSTRUCTIONS FOR USE: "CARE SHOULD BE TAKEN TO HOLD THE HUB STATIONARY AND TO REMOVE ANY SLACK IN THE INTRODUCER CATHETER TO ENSURE THE STENT IS NOT STRETCHED OR COMPRESSED LENGTHWISE DURING DEPLOYMENT (I.E., SO THAT THE STENT IS DEPLOYED TO ITS PROPER LENGTH)." PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MFG RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUAL ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    UPON DEPLOYMENT, THE STENT SHORTENED APPROXIMATELY 1-2 CM. THE STENT WAS POST DILATED AND THE FINAL IMAGING LOOKED FINE. NO ADVERSE EFFECTS TO THE PT WERE REPORTED AS OCCURRING AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662330 ZILVER PTX 35 DRUG/ELUTING STENT STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C992429

    Patients

    Seq Age Sex Outcome Treatment
    1