BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 6577797 · Received May 19, 2017

    Report

    Report Number
    3001845648-2017-00183
    Event Type
    Injury
    Date Received
    May 19, 2017
    Report Date
    April 21, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002385167
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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 PMA/510(K) # P100022/S014 THE ZISV6-35-125-8-60-PTX DEVICE OF LOT NUMBER C1231564 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE CUSTOMER WAS REQUESTED TO PROVIDE IMAGES OF THE INCIDENT. THE INVESTIGATION WILL BE UPDATED ONCE THE IMAGES ARE RECEIVED AND EVALUATED. FROM CUSTOMER TESTIMONY, THE COMPLAINT DEVICE WAS ADVANCED OVER AN UNKNOWN WIREGUIDE, AND IT IS UNKNOWN IF THE DEVICE WAS FLUSHED PRIOR TO USE. IT IS UNKNOWN IF PREDILATION WAS CONDUCTED PRIOR TO ADVANCING THE STENT, OR IF THE PATIENT HAD A CALCIFIED OR TORTUOUS ANATOMY. THE STENT PREMATURELY DEPLOYED IN THE AORTA OF THE PATIENT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. WITH THE INFORMATION PROVIDED, AND AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL ZISV6 (ZILVER PTX THUMBWHEEL) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS 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 C1231564. ACCORDING TO INFORMATION PROVIDED, THE PATIENT REQUIRED SECONDARY SURGERY TO REMOVE THE STENT FROM THE PATIENT¿S AORTA. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ACCESS WAS THROUGH BRACHIAL ARTERY. DURING ADVANCEMENT TO THE SFA, THE STENT BEGAN TO DEPLOY BEFORE RELEASING THE SAFETY; DEVICE DEPLOYED IN AORTA. PATIENT WAS SENT TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359369 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002385167

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention