BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 6338840 · Received February 17, 2017

    Report

    Report Number
    3001845648-2017-00050
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    October 1, 2015
    Report Date
    February 17, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002513416
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 ZIV6-35-125-6.0-40-PTX STENT OF LOT NUMBER C771050 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION AVAILABLE A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ACCORDING TO INFORMATION PROVIDED, RESTENOSIS WAS CONFIRMED IN THE LESION. IT IS KNOWN THAT THE CUSTOMER HAD PRE-EXISTING CONDITIONS INCLUDING CORONARY ARTERY DISEASE, HYPERTENSION AND DIABETES TYPE II. IN ADDITION, REST PAIN AND ULCERS WERE OBSERVED ON THE PATIENT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: 1. ANGIOGRAPHY FROM THE SECONDARY INTERVENTION WAS PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE ANGIOGRAPHY WAS INCOMPLETE. IT PRIMARILY CONSISTED OF IMAGING DURING POPLITEAL ARTERY (PA) AND INFRA-POPLITEAL ARTERY ANGIOPLASTY. ONLY TWO CONSECUTIVE ANGIOGRAPHIC RUNS DEMONSTRATED THE SFA. 3. THREE STENTS HAD BEEN IMPLANTED IN THE SFA. ONE WAS POSITIONED AT THE PROXIMAL END AND THE OTHER TWO AT THE DISTAL END. 4. THE PROXIMAL STENT WAS 6X50MM. ALTHOUGH RESOLUTION OF THE STENT ELEMENTS WAS LIMITED, THE STENT APPEARED STRETCHED AND LIKELY WAS A 6X40MM STENT. THE STENT HAD FOUR END MARKERS, AN APPEARANCE CONSISTENT WITH A ZILVER STENT. 5. THE TWO DISTAL STENTS WERE 6X40MM STENTS. ALTHOUGH NOT DEFINITE, THE ONLY IMAGE OF THESE STENTS STRONGLY SUGGESTED SIX END MARKERS ON EACH. THIS WOULD BE CONSISTENT WITH SMART STENTS NOT ZILVER STENTS. THESE STENTS WERE OVERLAPPED 7MM. 6. ALL THE STENTS WERE LINED WITH NEOINTIMAL HYPERPLASIA. THE PROXIMAL STENT WAS NARROWED 45% IN ITS CRANIAL END AND 53% IN ITS DISTAL END. THE CRANIAL MOST DISTAL SFA STENT WAS NARROWED 53% JUST SUPERIOR TO THE OVERLAP. THE CAUDAL MOST DISTAL STENT WAS NARROWED 53% AT ITS MIDDLE AND 55% AT ITS DISTAL END. 7. THE MID RIGHT SFA WAS NARROWED 55%. 8. NO IMAGING OR EVIDENCE OF IN-STENT OR MID SFA STENOSIS ANGIOPLASTY WAS PRESENT EXCEPT FOR POSSIBLE NON FLOW LIMITING LINEAR DISSECTION OF THE NEOINTIMAL HYPERPLASIA WITHIN THE DISTAL MOST STENT. HOWEVER THIS APPEARANCE COULD HAVE BEEN MADE BY UNTREATED NEOINTIMAL HYPERPLASIA. 9. OUTFLOW WAS LIMITED BY PA STENOSES OF 72% AND 60%. THESE STENOSES WERE IMPROVED TO 40% POST ANGIOPLASTY. 10. RUNOFF WAS SINGLE VESSEL VIA PERONEAL ARTERY RECONSTITUTION OF THE DISTAL POSTERIOR TIBIAL ARTERY. THE LATERAL PLANTAR ARTERY AND PEDAL ARCH WERE OCCLUDED. THE DISTAL MEDIAL PLANTAR ARTERY AND DORSAL PEDIS ARTERY WERE SEVERELY NARROWED. 11. CONSIDERABLE TIME AND EFFORT DURING THE INTERVENTION WAS INVESTED IN RECANALIZATION AND ANGIOPLASTY OF A MID-RIGHT ANTERIOR TIBIAL ARTERY OCCLUSION AND ATTEMPTED RECANALIZATION OF THE PLANTAR ARCH. THESE INTERVENTIONS WERE FACILITATED BY THE ANTEGRADE RIGHT COMMON FEMORAL ARTERY ANTEGRADE ACCESS. IF THE ANGIOPLASTY OF THE IN-STENT STENOSES AND MID SFA STENOSIS WERE THE PRIMARY FOCUS, THE INTERVENTION COULD HAVE BEEN PERFORMED MORE EASILY FROM A LEFT CFA RETROGRADE ACCESS. 12. RESTORATION OF THE RIGHT ANTERIOR TIBIAL ARTERY WAS SUCCESSFUL. PEDAL ARCH RESTORATION WAS NOT. THE SECOND AND FIFTH TOES HAD BEEN AMPUTATED AT THE METATARSAL PHALANGEAL JOINTS. 13. THE ARTERIES WERE DIFFUSELY HEAVILY CALCIFIED IN A RELATIVELY LINEAR DISTRIBUTION CONSISTENT WITH END STAGE RENAL INSUFFICIENCY AND DIALYSIS. THE LIBERAL USE OF CONTRAST WAS FURTHER EVIDENCE THAT THE PATIENT WAS ON CHRONIC DIALYSIS. IMPRESSION: 1. ALTHOUGH IN-STENT STENOSIS FROM NEOINTIMAL HYPERPLASIA WAS CONFIRMED, WHICH STENT REPRESENTED THE COMPLAINT RESTENOSIS CANNOT BE DETERMINED. OF THE THREE STENTS PRESENT, ONLY THE PROXIMAL MOST STENT WAS A ZILVER STENT. THE DISTAL TWO STENTS WERE LIKELY SMART STENTS. HOWEVER, ONLY THE MOST DISTAL STENT DEMONSTRATED ANY POTENTIAL SIGN OF THE REPORTED ANGIOPLASTY. 2. THE PROXIMAL MOST STENT LIKELY WAS A 6X40MM STENT STRETCHED TO 50MM. 3. THE PA, ANTERIOR TIBIAL ARTERY, AND FOOT ARTERY DISEASE WERE CONSIDERED PRIMARY TO THE CLINICAL COMPLAINT OF TISSUE LOSS. OTHERWISE, SFA INTERVENTION WOULD HAVE BEEN PERFORMED FIRST. HAD THE SFA DISEASE BEEN CONSIDERED PRIMARY, THE ACCESS WOULD HAVE MOST LIKELY BEEN RETROGRADE FROM THE LEFT CFA. 4. STENT PATENCY WAS CHALLENGED BY COEXISTENT SFA AND PA STENOSES AND POOR RUNOFF. 5. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. 6. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. STENT PATENCY WAS CHALLENGED BY COEXISTENT SFA AND POPLITEAL ARTERY STENOSES AND POOR RUNOFF. 7. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. A 6X40MM ZILVER STENT WAS LIKELY IMPLANTED STRETCHED TO 50MM. 8. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED.WHICHEVER STENT WAS THE COMPLAINT ZILVER STENT, IT WAS NARROWED AT LEAST 53% BY NEOINTIMAL HYPERPLASIA. 9. CAUSE OF ADVERSE EVENTS WAS OBSERVED. THE CLINICAL COMPLAINT OF TISSUE LOSS AND REST PAIN WERE PRIMARILY RELATED TO SEVERE PA STENOSIS, ANTERIOR TIBIAL ARTERY OCCLUSION, AND MULTI-VESSEL FOOT DISEASE CONTRIBUTING TO PEDAL ARCH OCCLUSION. BASED ON THE IMAGING REVIEW, THE OBSERVATION OF STENT STRETCHING IS CONFIRMED. A 6X40MM ZILVER STENT WAS LIKELY IMPLANTED STRETCHED TO 50MM. FOLLOWING THIS IMAGING REVIEW, THE INDEPENDENT REVIEWER WAS CONTACTED TO DETERMINE IF THE OBSERVATION OF STENT STRETCHING WAS RELATED TO THE RESTENOSIS REPORTED. THE FOLLOWING WAS RECEIVED: ¿...THE STENT COULD NOT OF STRETCHED ON ITS OWN BUT WOULD HAVE BEEN IMPLANTED THAT WAY. THE ELONGATED STENT WAS AN OBSERVATION THAT MAY OR MAY NOT BE RELATED TO NEOINTIMAL HYPERPLASIA. IT IS UNLIKELY BUT POSSIBLE. DECREASED RADIAL FORCE, LESS DRUG DENSITY, OR POSSIBLY EVEN THE STENT IRRITATING THE INTIMA IN THE STRETCHED STATE COULD HAVE INCREASED THE PROBABILITY OF NEOINTIMAL HYPERPLASIA. THE MAIN REASON TO RECORD THE FINDING IS FOR POSSIBLE FUTURE REFERENCE. IF OTHER CASES DEMONSTRATE ADVERSE FINDINGS ASSOCIATED WITH STRETCHED STENTS THEN THE OBSERVATIONS BECOME COLLECTIVELY USEFUL¿AT PRESENT WE CANNOT CONCLUDE THAT NEOINTIMAL HYPERPLASIA AND THE STRETCHED STENT ARE CORRELATED¿ AS STATED BY THE INDEPENDENT REVIEWER, THE STENT WAS LIKELY IMPLANTED STRETCHED AS IT COULD NOT HAVE STRETCHED ON ITS' OWN. HOWEVER AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. IT CAN BE NOTED THAT AS PER THE PACKAGING INSERT, TO PREVENT ELONGATION OF THE STENT DURING DEPLOYMENT THE FOLLOWING IS ADVISED: ¿CARE SHOULD BE TAKEN TO HOLD THE HUB STATIONARY AND TO REMOVE ANY SLACK IN THE INTRODUCER SHEATH TO ENSURE THE STENT IS NOT STRETCHED OR COMPRESSED LENGTHWISE DURING DEPLOYMENT. THIS SHOULD ENABLE THE STENT TO BE DEPLOYED TO ITS PROPER LENGTH. ¿ "AS DEPLOYMENT OCCURS, CONTINUE SLIDING THE STAMPED HANDLE TOWARD THE HUB IN A SLOW, SMOOTH AND CONSISTENT FASHION. ONCE GOOD WALL APPOSITION HAS BEEN ACHIEVED BY THE DISTAL 1-2CM OF THE STENT, WATCH THE PROXIMAL STENT MARKERS TO ENSURE THEY REMAIN STATIONARY - THIS INDICATES THAT THERE IS NO COMPRESSION OR ELONGATION OF THE STENT" 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. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH LOT NUMBER C771050. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THIS LOT NUMBER. ACCORDING TO INFORMATION PROVIDED PTA WAS PERFORMED AND THE PATIENT HAD A FAVORABLE OUTCOME. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF THE IMAGE REVIEW AND UPDATE TO THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: ON (B)(6) 2012: ZIV6-35-125-6.0-40-PTX X 1 WAS PLACED IN THE RIGHT SFA. ON (B)(6) 2015: RESTENOSIS WAS CONFIRMED IN THE LESION. (REST PAIN AND ULCER WERE OBSERVED.) THEN, PTA WAS PERFORMED AND THE PATIENT HAD A FAVOURABLE OUTCOME. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION CONFIRMING STENT STRETCHING. IT IS UNCLEAR IF THE ELONGATED STENT WAS AN OBSERVATION THAT MAY OR MAY NOT BE RELATED TO NEOINTIMAL HYPERPLASIA, WHICH RESULTED IN RESTENOSIS AND REQUIRED INTERVENTION. ADDITIONAL CLARIFICATION HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012: ZIV6-35-125-6.0-40-PTX X 1 WAS PLACED IN THE RIGHT SFA. ON (B)(6) 2015: RESTENOSIS WAS CONFIRMED IN THE LESION. (REST PAIN AND ULCER WERE OBSERVED.) THEN, PTA WAS PERFORMED AND THE PATIENT HAD A FAVOURABLE OUTCOME. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION CONFIRMING STENT STRETCHING. IT IS UNCLEAR IF THE ELONGATED STENT WAS AN OBSERVATION THAT MAY OR MAY NOT BE RELATED TO NEOINTIMAL HYPERPLASIA, WHICH RESULTED IN RESTENOSIS AND REQUIRED INTERVENTION. ADDITIONAL CLARIFICATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122767 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002513416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention