BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 5666255 · Received May 19, 2016

    Report

    Report Number
    3001845648-2016-00134
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 22, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002353081
    PMA / PMN Number
    P100022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: P100022/S014. THIS INVESTIGATION ADDRESSES ZISV6-35-80-6.0-60-PTX OF LOT NUMBER C1216360. REFER TO (B)(4) FOR INVESTIGATION DETAILS FOR THE FIRST DEVICE (ZISV6-35-80-6.0-80-PTX). CATALOG # 1X ZISV6-35-80-6.0-60-PTX OF LOT NUMBER C1216360 WAS RETURNED TO COOK IRELAND FOR EVALUATION. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. STENT REMAINS IMPLANTED IN THE PATIENT. ON EVALUATION OF THE RETURNED DEVICE IT HAS BEEN CONFIRMED THAT THE STENT HAD BEEN DEPLOYED. THE ENTIRE DELIVERY SYSTEM HAS BEEN EXAMINED FOR DAMAGE AND NO DAMAGE WAS DETECTED. USING CALIBRATED RULER, DELIVERY SYSTEM LENGTH MEASURED 79.5CM AND WAS NOTED TO BE AS PER SPECIFICATION. USING A SYRINGE OF WATER THE DEVICE WAS FLUSHED WITH NO ISSUES NOTED. THE SYSTEM WAS ADVANCED OVER A 0.035¿¿ WIRE GUIDE, NO RESISTANCE NOTED. THE HANDLE WAS OPENED AND INNER COMPONENTS WERE VISUALLY EXAMINED. IT HAS BEEN CONFIRMED THAT ALL COMPONENTS WERE ASSEMBLED CORRECTLY. UPON EVALUATION OF THE RETURNED DEVICE, IT HAS BEEN CONFIRMED THAT THE DEVICE WAS MANUFACTURED CORRECTLY AND THERE WERE NO ISSUES WITH THE ZILVER PTX STENT DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN PROVIDED FOR THIS FILE. IT IS KNOWN THAT A TERUMO STANDARD 0.035 WIRE GUIDE WAS USED DURING THIS PROCEDURE. POST STENT DEPLOYMENT THERE WAS NO EVIDENCE OF COMPRESSION OR DEFORMATION. THE PATIENT`S LESION WAS HEAVILY CALCIFIED. PRE-DILATATION WAS NOT EFFECTIVE, THE DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION WITH LOW FRICTION. THIS DEVICE, ZILVER PTX (ZISV6-35-80-6.0-60-PTX) DEPLOYED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING A IPSILATERAL/ ANTEGRADE APPROACH. THE ACCESS SHEATH USED IN THIS PROCEDURE WAS RETURNED WITH THE DEVICE ASSOCIATED WITH (B)(4). IT IS UNCLEAR IF THE STABILITY SHEATH WAS WITHIN THE ACCESS SHEATH DURING STENT DEPLOYMENT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THESE WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: FIVE IMAGES ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. ONE IS OF THE ACCESS SHEATH AND AN ANGLED GLIDE WIRE. THE SECOND IS OF THE BALLOON AND TRAILBLAZER SUPPORT CATHETER, AND THE FINAL 3 WERE ANGIOGRAPHIC IMAGES PHOTOGRAPHED OFF THE MONITOR. THE SHEATH, BALLOON, SUPPORT CATHETER AND WIRE ALL APPEAR NORMAL. THE SHEATH WAS SHORT. THE CONTROL ANGIOGRAM ALLUDED TO IN THE COMPLAINT REPORT MUST HAVE BEEN PERFORMED THROUGH THIS SHEATH FROM A RIGHT ANTEGRADE APPROACH. THE FIRST ANGIOGRAPHIC IMAGE DEMONSTRATES THE RIGHT SFA OCCLUSION PRIOR TO RECANALIZATION. ANOTHER MANUFACTURE'S STENT, LIKELY EITHER A 7 OR 8MM DIAMETER 10CM LONG BARD LUMINEXX OR EV3 PROTEGE, WAS PREVIOUSLY IMPLANTED IN THE DISTAL SFA ACROSS THE ADDUCTOR CANAL. THE SFA WAS OCCLUDED PROXIMAL TO THE STENT. THE OCCLUSION LIKELY EXTENDED AT LEAST 5CM TO THE SUPPORT CATHETER TIP. THE STENT, ALTHOUGH RECONSTITUTED BY SMALL COLLATERALS, WAS SEVERELY NARROWED FROM CLOT AND OR NEOINTIMAL HYPERPLASIA AND MODERATELY EXTERNALLY COMPRESSED. THE HEAVILY CALCIFIED ATHEROMATOUS PLAQUE THROUGH THE SEGMENT WAS EVIDENT BY SUBTRACTION ARTIFACT. THE OTHER 2 IMAGES DEMONSTRATE THE COMPLAINT STENT AFTER IMPLANTATION. THE FIRST IN THE SEQUENCE SHOWS THE 6X80MM STENT DEPLOYED FROM THE PREEXISTING STENT PROXIMALLY TERMINATING IN THE MID OCCLUSION. THE DEPLOYED STENT LENGTH WAS 40MM. THE STENT WAS EXPANDED TO NO MORE THAN 4MM IN THE PREEXISTING STENT, 4.7MM AT ITS MIDPOINT, AND 3.6MM AT ITS PROXIMAL END. INCREASED DENSITY IN THE MID STENT REPRESENTS PRIMARILY CALCIFICATION AND NOT CONCERTINAED STENT. THE THIRD IMAGE DEMONSTRATES SHORTENING OF THE 6X60MM ZILVER PTX STENT TO 32MM. THE STENT WAS IMPLANTED FROM THE PROXIMAL 6X80MM ZILVER STENT PAST THE DENSE CALCIFIED ATHEROMA INTO WHAT WAS LIKELY PROXIMAL PATENT SFA. THE STENT WAS CONSTRAINED TO 4.5MM. MID STENT INCREASED DENSITY REPRESENTS PRIMARILY CALCIFICATION AND NOT CONCERTINAED STENT. IMPRESSION: SHORTENING OF BOTH IMPLANTED STENTS TO HALF OF THE DESIGN LENGTH WAS CONFIRMED. THE STENTS WERE IMPLANTED IN A HEAVILY CALCIFIED OCCLUSION THAT DEMONSTRATED SIGNIFICANT RECOIL EVEN AFTER STENT IMPLANTATION. SEVERELY CALCIFIED RECOILED PLAQUE HAS THE POTENTIAL TO EXTRACT THE STENT IF INDIVIDUAL STENT APICES EMBED AND HELD IN PLAQUE AT PERPENDICULAR ANGLES AS THEY ARE REVEALED. THE LUMEN IRREGULARITY ESSENTIALLY CREATES A MUCH LONGER LUMEN TO STENT. STENT RADIAL FORCE CAN REMODEL UN-CALCIFIED PLAQUE FLAT MUCH EASIER THAN HEAVILY CALCIFIED PLAQUE. THE STENTS WERE DEPLOYED FROM AN ANTEGRADE APPROACH. THIS FACTOR IS COMMON TO THE OVERWHELMING MAJORITY OF STENT SHORTENING COMPLAINTS AND REFLECTS THE DIFFICULTY IN NOT INADVERTENTLY ADVANCING THE CANNULA WHILE RETRACTING THE DELIVERY SHEATH WITH A SUSPENDED DELIVERY SYSTEM THROUGH AN ACUTELY ANGULATED ACCESS SHEATH. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. THE OCCLUSION WAS HEAVILY CALCIFIED AND REQUIRED AN ANTEGRADE APPROACH. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE STENTS WERE IMPLANTED COMPRESSED AT LEAST 50%. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. BASED ON THE IMAGES PROVIDED, THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS THE IMAGE DEMONSTRATED STENT SHORTENING OF THE STENT (ZISV6-35-80-6.0-60-PTX). FROM THE IMAGE REVIEW FINDING NUMBER 7 '..THE THIRD IMAGE DEMONSTRATES SHORTENING OF THE 6X60MM ZILVER PTX STENT TO 32MM..' FROM THE IMAGE REVIEW IMPRESSION NUMBER 1, ¿SHORTENING OF BOTH IMPLANTED STENTS TO HALF OF THE DESIGN LENGTH WAS CONFIRMED. THE STENTS WERE IMPLANTED IN A HEAVILY CALCIFIED OCCLUSION THAT DEMONSTRATED SIGNIFICANT RECOIL EVEN AFTER STENT IMPLANTATION. THIS COINCIDES WITH ADDITIONAL INFORMATION PROVIDED FOR THIS FILE: 'SECOND ZPTX INSTEAD OF 6CM ONLY 3,24CM". ACCORDING TO THE COMPLAINT INFORMATION PROVIDED, THE COMPLAINT DEVICE WAS PLACED IN THE PATIENT DUE TO STENT SHORTENING OF A PREVIOUSLY PLACED STENT ((B)(4)). THE COMPLAINT DEVICE WAS PLACED PROXIMAL TO THE PREVIOUSLY PLACED STENT. POST DEPLOYMENT IT WAS KNOWN THAT THE COMPLAINT DEVICE ALSO SHORTENED ¿..BOTH STENTS ARE SHORTENING: THE 8CM TO 4CM AND THE 6CM TO 3CM..¿ THE STENTS REMAINED IMPLANTED AS INTENDED. THE DELIVERY SYSTEMS WERE REMOVED FROM THE PATIENT AND THE USER POST DILATED THE DEVICES USING DORADO 5F 6MM/10CM. THE USER CONFIRMED ¿VERY STRONG STENT SHORTENING - BECAUSE OF THE VERY CALCIFIED WALL AND SITUATION¿. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT HAD A FAVORABLE OUTCOME. THE FOLLOWING INFORMATION IS INCLUDED IN INSTRUCTION FOR USE: ¿THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT IS DESIGNED NOT TO SHORTEN UPON DEPLOYMENT.¿ BASED ON THE IMAGE REVIEW IMPRESSION THE MOST LIKELY CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO THE PATIENT`S HEAVILY CALCIFIED OCCLUSION. IN ADDITION, AS THE PROCEDURE WAS COMPLETED IPSILATERALLY USING AN 80CM SYSTEM IS IT POSSIBLE THAT THE STABILITY SHEATH WAS NOT KEPT WITHIN THE ACCESS SHEATH DURING DEPLOYMENT. THE POTENTIAL FAILURE MODE COULD CAUSE THE STENT TO COMPRESS DURING DEPLOYMENT WITHOUT THE STABILITY SHEATH BEING WITHIN THE ACCESS SHEATH THEREFORE RESULTING IN THE STENT SHORTENING. HOWEVER AS THE CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTINGS, A DEFINITIVE ROOT CAUSE OF THIS STENT SHORTENING CANNOT BE DETERMINED. IT CAN BE NOTED, THAT AS PER INSTRUCTIONS FOR USE IT STATES: ¿ENSURE THE DISTAL END OF THE STABILITY SHEATH IS INSIDE THE ACCESS SHEATH¿. INPUT WAS REQUESTED FROM R&D AND THE FOLLOWING COMMENTS WERE RECEIVED: ¿YES THERE IS A POTENTIAL THAT THE SS WAS NOT IN THE ACCESS SHEATH LEADING TO THE STENT SHORTENING.." IT MAY BE NOTED THAT A PROJECT (ZILVER THUMBWHEEL STABILITY SHEATH COLOUR CHANGE) HAS BEEN INITIATED TO PROVIDE A MORE USER FRIENDLY ZILVER PTX DEVICE. THE INSTRUCTIONS AVAILABLE FOR OPERATING THE ZILVER PTX THUMBWHEEL DEVICE IS TO ENSURE THE STABILITY SHEATH MUST BE WITHIN THE ACCESS SHEATH. HOWEVER THE TRANSITION BETWEEN THE STABILITY SHEATH AND STENT RETRACTION SHEATH CAN BE UNCLEAR TO THE USER AS BOTH SHEATHS ARE BLUE; CHANGING THE COLOUR OF THE STABILITY SHEATH TIP WILL PROVIDE A VISUAL REFERENCE TO THE USER. STABILITY SHEATH TO BE CHANGED TO INCLUDE A RED TIP, THIS WILL PROVIDE A VISUAL REFERENCE FOR THE STABILITY SHEATH TO THE STENT RETRACTION SHEATH TRANSITION. THE RED TIP IS A BRIGHT AND USER FRIENDLY VISUAL AID. 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT HAS A FAVORABLE OUTCOME. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    STENT SHORTENING OCCURRED IN A CALCIFIED LESION. USING THE SELDINGER TECHNIQUE, A 6F STANDARD SHEATH/ TERUMO WAS USED, OVERVIEW ON THE RIGHT SIDE, WIRE CHANGED TO TERUMO STANDARD 0.035 INCH, RECANALIZATION OF THE OCCLUSION CAREFULLY WITH A SUPPORT CATHETER TRAILBLAZER 5F. SUBSEQUENTLY, DILATION WAS CARRIED OUT WITH 5F DORADO (5MM/10CM). CONTROL ANGIOGRAM SHOWED SIGNIFICANT ATHEROSCLEROSIS WALL CHANGES, WHICH INDICATES THE STENT WAS REQUIRED. POSITIONING OF THE STENT HAD NO PROBLEMS WITH THE SYSTEM, THERE WAS NO FRICTION AND THE IMPLANTATION OF THE ZPTX 6MM/8CM THUMB WHEEL HAD LITTLE RESISTANCE AT THE BEGINNING WHICH THEN IMPROVED. STENT SHORTENED - IT WAS APPROXIMATELY FROM APPROXIMATELY 6CM TO 3CM AS PER PICTURE. POSITION/ IMPLANTATION ZPTX 6MM/6CM FOR EXTENSION (DIRECTION PROXIMAL). SYSTEMS WERE REMOVED WITHOUT ANY PROBLEMS. POST DILATATION WITH DORADO 5F 6MM/10CM SHOWED SUCCESSFUL RESULTS WITH FREE OUTFLOW. NO IMPACT TO THE PATIENT. STENT SHORTENING MAY BE DUE TO THE CALCIFIED WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320793 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002353081

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR