BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4196135 · Received October 21, 2014

    Report

    Report Number
    3001845648-2014-00191
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    October 4, 2013
    Report Date
    September 22, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZIV6-35-125-6.0-120-PTX DEVICE IN QUESTION WAS IMPLANTED IN THE PATIENT AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED. ALTHOUGH REQUESTED, IMAGES RELATING TO THIS EVENT HAVE NOT BEEN PROVIDED. IT MAY BE NOTED THAT RESTENOSIS 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 (OR AMPLIFIES) TO THE RESTENOSIS PROCESS. BASED ON THE PHYSICIAN'S COMMENTS THE POSSIBILITY OF RESTENOSIS OCCURRENCE WAS HIGHLY LIKELY DUE TO THE LENGTH OF THE LESION. HOWEVER, THE DEFINITE ROOT CAUSE OF RESTENOSIS CANNOT BE CONCLUSIVELY DETERMINED. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE MANUFACTURING RECORDS FOR THE ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT COULD NOT BE REVIEWED AS THE SPECIFIC LOT NUMBER WAS NOT PROVIDED. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. ACCORDING TO INSTRUCTIONS FOR USE RESTENOSIS OF THE STENTED IS NOTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. PTA WAS PERFORMED AGAINST THE RESTENOSIS AND THE PATIENT RECOVERED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A ZFV6-35-80-6-40 AND THREE ZIV6-35-125-6.0-120-PTX WERE PLACED IN THE RIGHT SFA. (B)(6) 2013 RESTENOSIS (50-99 PERCENT) IN THE LESION WHERE STENTS WERE IMPLANTED WAS CONFIRMED. WORSENED RUTHERFORD WAS OBSERVED TO THE PATIENT. ON (B)(6) 2014 PTA WAS PERFORMED AGAINST THE RESTENOSIS AND THE PATIENT RECOVERED. IT IS UNKNOWN HOW MANY OUT OF THE STENTS ARE RELATED TO THIS RESTENOSIS. THIS REPORT RELATES TO ONE ZIV6-35-125-6.0-120-PTX DEVICE. REFERENCE ALSO RELATED REPORTS 3001845648-2014-00190 AND 3001845648-2014-00192.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669452 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention