BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 8646211 · Received May 28, 2019

    Report

    Report Number
    3001845648-2019-00229
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    March 28, 2019
    Report Date
    April 30, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002248882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # = P100022. 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. DEVICE EVALUATION: IT SHOULD BE NOTED THAT THERE ARE TWO INVESTIGATIONS RELATED TO THIS COMPLAINT. THIS FILE INVESTIGATES THE POSSIBLE STENT FRACTURE AS IDENTIFIED WITHIN THE IMAGING REVIEW. FOR DETAILS OF THE SECOND INVESTIGATION PLEASE REFER TO COMPLAINT FILE PR 260484. THE ZIV6-35-125-6-40-PTX DEVICE OF LOT NUMBER C972172 INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIV6-35-125-6-40-PTX DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZIV6-35-125-6-40-PTX OF LOT NUMBER C972172 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C972172. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. HOWEVER, IT SHOULD BE NOTED THAT STENT STRUT FRACTURE AND PSEUDOANEURYSM FORMATION ARE LISTED AS KNOWN POTENTIAL ADVERSE EVENTS WITHIN THE IFU. IMAGE REVIEW: 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: IMPRESSION: 1. THE COMPLAINT OF THROMBUS IN AND PROXIMAL THE STENT POSSIBLY RELATED TO THE STENT IS NOT CONFIRMED. ONLY THROMBUS IN THE DISTAL STENT IS CONFIRMED. BECAUSE THE 50%SFA STENOSIS ABOVE THE STENT PROGRESSED TO OCCLUSIVE PLAQUE THAT CONTINUED INTO THE STENT AS NIH, THE STENT WAS BYSTANDER RATHER THAN CAUSALLY RELATED. 2. THE OCCLUSION WAS AGGRAVATED BY THE MODERATE SFA ATHEROSCLEROTIC STENOSIS DISTAL THE STENT PROGRESSING TO SEVERE. 3. AFTER THE SECONDARY INTERVENTION, BECAUSE THE ZIV6-35-125-6-40-PTX WAS COMPLETELY COVERED BY THE 20CM STENT, THE ZIV6-35-125-6-40-PTX WAS EXCLUDED FROM THE CIRCULATION. 4. ATHEROSCLEROTIC DISEASE PROGRESSION WAS CONSISTENT WITH THE REPORT CONTINUED TOBACCO ABUSE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS AND/OR DIFFICULT PATIENT ANATOMY. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT THE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION, CAROTID DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), HYPERCHOLESTEROLEMIA AND IS A CURRENT SMOKER. FROM THE IMAGING REVIEW PROVIDED IT IS KNOWN THAT THE PATIENT EXHIBITED ATHEROSCLEROTIC STENOSIS. IT IS POSSIBLE THAT THE AFOREMENTIONED MEDICAL CONDITIONS MAY HAVE EXERTED EXCESSIVE FORCE ON THE STENT POSSIBLY CAUSING A STENT FRACTURE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE(S) ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: ¿AT 1.5 YEARS, FOLLOW UP SEGMENTAL PRESSURES DEMONSTRATED ANKLE BRACHIAL INDICES IN THE CLAUDICATION RANGE AND MONOPHASIC WAVEFORMS FROM THE CFAS THROUGH THE ANKLES BILATERALLY. THIS SUGGESTED BILATERALLY AORTIC ILIAC HEMODYNAMICALLY SIGNIFICANT STENOSIS. ON THE RIGHT, THIS WAS FURTHER SUPPORTED BY INCREASED PSV AND SPECTRALLY BROADENING AT THE RIGHT ILIAC BYPASS LIMB AND CFA ANASTOMOSIS CONSISTENT WITH A NEW 50-90% STENOSIS. MULTIPLE IN-STENT STENOSES AND A POSSIBLE STENT FRACTURE IMPINGING ON THE MID-SFA LUMEN AND CAUSING A SMALL PSEUDOANEURYSM HAD DEVELOPED. ALTHOUGH ULTRASOUND CANNOT INFALLIBLY RESOLVE STENT LAYERS, ONLY ONE LAYER OF STENT WAS IMAGED AT THE SUSPECTED FRACTURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441751 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD G24888 C972172 10827002248882

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR