BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4213054 · Received October 24, 2014

    Report

    Report Number
    3001845648-2014-00201
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    August 12, 2014
    Report Date
    September 25, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ZILVER PTX DEVICE INVOLVED IN THIS COMPLAINT IS AS FOLLOWS: ZIV6-35-125-7.0-120-PTX OF LOT NUMBER. C775586. THE STENT WAS IMPLANTED IN THE PATIENT, THEREFORE, IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ALTHOUGH REQUESTED, IMAGES RELATING TO THIS EVENT HAS NOT BEEN PROVIDED. THE PATIENT PRESENTED WITH THE FOLLOWING PRE-EXISTING CONDITIONS; CAROTID DISEASE, HYPERCHOLESTEROLEMIA, CURRENT SMOKER. THE FOLLOWING COMMENT WAS PROVIDED BY THE PHYSICIAN; "REINTERVENTION WAS PERFORMED DUE TO THE WORSEN CLAUDICATION. DIFFUSE RESTENOSIS IN THE STENT WAS OBSERVED. THE CAUSE OF THIS EVENT IS UNKNOWN. IT IS POSSIBLE THAT THE SAME EVENT WOULD HAVE OCCURRED EVENT EVEN IF BMS HAD BEEN PLACED". IT MAY BE NOTED THAT RE-STENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PTA AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS TO (OR AMPLIFIES) THE RESTENOSIS PROCESS. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTION CHECKS TO ENSURE DEVICE INTEGRITY. FROM INFORMATION PROVIDED, THE PATIENT RECOVERED. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. COMPLAINTS OF THIS NATURE CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THREE ZIV6-35-125-7.0-120-PTX OF THE SAME LOT# WERE PLACED IN THE LEFT SFA. ON (B)(6) 2014 RESTENOSIS (50-99%) IN THE LESION WHERE STENTS WERE IMPLANTED WAS CONFIRMED. WORSENED CLAUDICATION WAS OBSERVED TO THE PATIENT. PTA WAS PERFORMED AGAINST THE RESTENOSIS ON THE SAME DAY. ON (B)(6) 2014 THE PATIENT RECOVERED. THIS REPORT RELATES TO ONE ZIV6-35-125-7.0-120-PTX DEVICE. REFERENCE ALSO RELATED REPORTS 3001845648-2014-00200, 00199.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680053 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C775586

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention