BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 VASCULAR SELF-EXPANDING STENT

    MDR report key: 5740955 · Received June 22, 2016

    Report

    Report Number
    3001845648-2016-00164
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    April 26, 2016
    Report Date
    June 29, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002437736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P050017/S002 AND S003. THE INVESTIGATION INTO THIS EVENT IS CURRENTLY STILL UNDERWAY. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P050017/S002 AND S003. THE ZILVER STENT INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A SINGLE IMAGE PHOTOGRAPHED FROM THE ANGIOGRAPHY MONITOR WAS PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THIS WAS REVIEWED AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: A SINGLE IMAGE PHOTOGRAPHED FROM THE ANGIOGRAPHY MONITOR IS PROVIDED ALONG WITH THE COMPLAINT REPORT. THE TARGET LESION WAS A HEAVILY CALCIFIED PROXIMAL RIGHT SFA STENOSIS OR OCCLUSION WITH AN ACUTE. LATERAL " DOG LEG" ANGULATION SECONDARY TO DEFORMATION CAUSED BY THE SEVERELY CALCIFIED PLAQUE. ACCESS WAS LIKELY RETROGRADE FROM THE LEFT CFA AS NO SHEATH WAS IMAGED AT THE LEVEL OF THE MID RIGHT FEMORAL HEAD. THE PROXIMAL STENT WAS CONCERTINAED OVER A LENGTH OF 17MM. THE DISTAL MOST 20MM OF THE STENT DEPLOYED NORMALLY. THE STENT WAS CONSTRAINED BY HEAVILY CALCIFIED PLAQUE TO 4.6MM WITHIN THE "DOG LEG". A SECOND 80MM STENT WAS DEPLOYED TO A LENGTH OF 57MM THROUGH THE CONCERTINAED STENT. WHETHER THE STENT WAS ONLY LONGITUDINALLY COMPRESSED BUT ALSO CONCERTINAED CANNOT BE DETERMINED. A THIRD NON DEPLOYED STENT WAS PRESENT ACROSS BOTH STENTS. IMPRESSION: THE PROXIMAL PORTION OF THE FIRST IMPLANTED STENT WAS CONCERTINAED. THE STENT WAS CONSTRAINED AND DISTORTED BY THE RESISTANT HEAVILY CALCIFIED PLAQUE. CONSEQUENTLY TWO POSSIBLE MECHANISMS, INADVERTENT DELIVERY SYSTEM ADVANCEMENT DURING IMPLANTATION AND OR STENT EXTRACTION BY THE HEAVILY CALCIFIED IRREGULAR PLAQUE, WERE LIKELY THE CAUSE. THE SECOND IMPLANTED STENT WAS ALSO DEPLOYED LONGITUDINALLY SHORTENED. THE MECHANISMS WOULD BE SIMILAR TO THE FIRST STENT EXCEPT THAT THE STENT WOULD HAVE BEEN EXTRACTED BY THE CONCERTINAED STENT RATHER THAN CALCIFIED ATHEROMA. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. THE PLAQUE WAS HEAVILY CALCIFIED, IRREGULAR, AND RESISTANT TO EXPANSION. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE PROXIMAL STENT WAS DEPLOYED CONCERTINAED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. CLARIFICATION WAS REQUESTED REGARDING FINDING #6 RELATING TO AN UNDEPLOYED STENT AND THE FOLLOWING COMMENT WAS PROVIDED: "THE STENT WAS COMPLETELY WITHIN THE DELIVERY SYSTEM. NO DEPLOYMENT HAD BEGUN" BASED ON THE IMAGES PROVIDED, THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS THE IMAGE DEMONSTRATED STENT SHORTENING. ACCORDING TO THE IMAGE REVIEW FINDINGS #5, ¿A SECOND 80MM STENT WAS DEPLOYED TO A LENGTH OF 57MM THROUGH THE CONCERTINAED STENT. WHETHER THE STENT WAS ONLY LONGITUDINALLY COMPRESSED BUT ALSO CONCERTINAED CANNOT BE DETERMINED ". IN THIS CASE, THE INDEPENDENT REVIEWER HAS PROVIDED TWO POSSIBLE CAUSES OF STENT SHORTENING: ¿.. INADVERTENT DELIVERY SYSTEM ADVANCEMENT DURING IMPLANTATION AND OR STENT EXTRACTION BY THE HEAVILY CALCIFIED IRREGULAR PLAQUE, WERE LIKELY THE CAUSE¿. IN THIS CASE, ACCORDING TO ¿IMPRESSION #2¿ ¿THE MECHANISMS WOULD BE SIMILAR TO THE FIRST STENT EXCEPT THAT THE STENT WOULD HAVE BEEN EXTRACTED BY THE CONCERTINAED STENT RATHER THAN CALCIFIED ATHEROMA¿. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY SETTING, A DEFINITE ROOT CAUSE OF STENT SHORTENING CANNOT BE DETERMINED. AS PER THE INSTRUCTION FOR USE, THE ZILVER VASCULAR STENT IS INTENDED FOR USE IN THE ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9MM. IT CAN BE NOTED THAT ACCORDING TO COMPLAINT INFORMATION PROVIDED, THE DEVICE WAS USED FOR SFA STENTING PROCEDURE, WHICH WOULD BE CONSIDERED AS OFF LABEL USE. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PRIOR TO DISTRIBUTION ALL ZIV5-18-125-7-40 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P050017/S002 AND S003. THE ZILVER STENT INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A SINGLE IMAGE PHOTOGRAPHED FROM THE ANGIOGRAPHY MONITOR WAS PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THIS WAS REVIEWED AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: A SINGLE IMAGE PHOTOGRAPHED FROM THE ANGIOGRAPHY MONITOR IS PROVIDED ALONG WITH THE COMPLAINT REPORT. THE TARGET LESION WAS A HEAVILY CALCIFIED PROXIMAL RIGHT SFA STENOSIS OR OCCLUSION WITH AN ACUTE. LATERAL " DOG LEG" ANGULATION SECONDARY TO DEFORMATION CAUSED BY THE SEVERELY CALCIFIED PLAQUE. ACCESS WAS LIKELY RETROGRADE FROM THE LEFT CFA AS NO SHEATH WAS IMAGED AT THE LEVEL OF THE MID RIGHT FEMORAL HEAD. THE PROXIMAL STENT WAS CONCERTINAED OVER A LENGTH OF 17MM. THE DISTAL MOST 20MM OF THE STENT DEPLOYED NORMALLY. THE STENT WAS CONSTRAINED BY HEAVILY CALCIFIED PLAQUE TO 4.6MM WITHIN THE "DOG LEG". A SECOND 80MM STENT WAS DEPLOYED TO A LENGTH OF 57MM THROUGH THE CONCERTINAED STENT. WHETHER THE STENT WAS ONLY LONGITUDINALLY COMPRESSED BUT ALSO CONCERTINAED CANNOT BE DETERMINED. A THIRD NON DEPLOYED STENT WAS PRESENT ACROSS BOTH STENTS. IMPRESSION: THE PROXIMAL PORTION OF THE FIRST IMPLANTED STENT WAS CONCERTINAED. THE STENT WAS CONSTRAINED AND DISTORTED BY THE RESISTANT HEAVILY CALCIFIED PLAQUE. CONSEQUENTLY TWO POSSIBLE MECHANISMS, INADVERTENT DELIVERY SYSTEM ADVANCEMENT DURING IMPLANTATION AND OR STENT EXTRACTION BY THE HEAVILY CALCIFIED IRREGULAR PLAQUE, WERE LIKELY THE CAUSE. THE SECOND IMPLANTED STENT WAS ALSO DEPLOYED LONGITUDINALLY SHORTENED. THE MECHANISMS WOULD BE SIMILAR TO THE FIRST STENT EXCEPT THAT THE STENT WOULD HAVE BEEN EXTRACTED BY THE CONCERTINAED STENT RATHER THAN CALCIFIED ATHEROMA. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. THE PLAQUE WAS HEAVILY CALCIFIED, IRREGULAR, AND RESISTANT TO EXPANSION. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE PROXIMAL STENT WAS DEPLOYED CONCERTINAED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. CLARIFICATION WAS REQUESTED REGARDING FINDING #6 RELATING TO AN UNDEPLOYED STENT AND THE FOLLOWING COMMENT WAS PROVIDED: "THE STENT WAS COMPLETELY WITHIN THE DELIVERY SYSTEM. NO DEPLOYMENT HAD BEGUN". BASED ON THE IMAGES PROVIDED, THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS THE IMAGE DEMONSTRATED STENT SHORTENING. ACCORDING TO THE IMAGE REVIEW FINDINGS #5, ¿A SECOND 80MM STENT WAS DEPLOYED TO A LENGTH OF 57MM THROUGH THE CONCERTINAED STENT. WHETHER THE STENT WAS ONLY LONGITUDINALLY COMPRESSED BUT ALSO CONCERTINAED CANNOT BE DETERMINED". IN THIS CASE, THE INDEPENDENT REVIEWER HAS PROVIDED TWO POSSIBLE CAUSES OF STENT SHORTENING: ¿.. INADVERTENT DELIVERY SYSTEM ADVANCEMENT DURING IMPLANTATION AND OR STENT EXTRACTION BY THE HEAVILY CALCIFIED IRREGULAR PLAQUE, WERE LIKELY THE CAUSE¿. IN THIS CASE, ACCORDING TO ¿IMPRESSION #2¿ ¿THE MECHANISMS WOULD BE SIMILAR TO THE FIRST STENT EXCEPT THAT THE STENT WOULD HAVE BEEN EXTRACTED BY THE CONCERTINAED STENT RATHER THAN CALCIFIED ATHEROMA¿. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY SETTING, A DEFINITE ROOT CAUSE OF STENT SHORTENING CANNOT BE DETERMINED. AS PER THE INSTRUCTION FOR USE, THE ZILVER VASCULAR STENT IS INTENDED FOR USE IN THE ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9MM. IT CAN BE NOTED THAT ACCORDING TO COMPLAINT INFORMATION PROVIDED, THE DEVICE WAS USED FOR SFA STENTING PROCEDURE, WHICH WOULD BE CONSIDERED AS OFF LABEL USE. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PRIOR TO DISTRIBUTION ALL ZIV5-18-125-7-40 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    IMAGES RECEIVED AS A RESULT OF REPORT # 3001845648-2016-00140 CONFIRMED THAT AN ADDITIONAL ZILVER STENT ALSO PLACED DURING THE PROCEDURE WAS CONFIRMED TO HAVE SHORTENED ON DEPLOYMENT. THE STENT REMAINS IMPLANTED IN THE PATIENT. FDA MDR REPORTING REQUIRED BASED ON THE REPORTING MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY FOR THE MALFUNCTION ' STENT SHORTENING ON DEPLOYMENT'.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE CONCLUSION OF THE INVESTIGATION INTO THIS EVENT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: IMAGES RECEIVED AS A RESULT OF REPORT # 3001845648-2016-00140 CONFIRMED THAT AN ADDITIONAL ZILVER STENT ALSO PLACED DURING THE PROCEDURE WAS CONFIRMED TO HAVE SHORTENED ON DEPLOYMENT. THE STENT REMAINS IMPLANTED IN THE PATIENT. FDA MDR REPORTING REQUIRED BASED ON THE REPORTING MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY FOR THE MALFUNCTION ' STENT SHORTENING ON DEPLOYMENT'.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO AN ERROR NOTED WITH THE REPORTING DATE. THE NEW INFORMATION DATE WAS INCORRECTLY INPUTTED.THIS HAS BEEN CORRECTED AND THEIR IS NO ADDITIONAL IMPACT TO THE REMAINDER OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395199 ZILVER 518 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD 10827002437736

    Patients

    Seq Age Sex Outcome Treatment
    1