BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4283394 · Received November 19, 2014

    Report

    Report Number
    3001845648-2014-00248
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    July 9, 2013
    Report Date
    October 27, 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

    (B)(4). THE ZILVER PTX DEVICE INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ALTHOUGH REQUESTED IMAGES RELATING TO THIS EVENT HAVE NOT BEEN RECEIVED. 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 (OR AMPLIFIES) TO THE RESTENOSIS PROCESS. RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES RELATED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. DUE TO LACK OF IMAGES NO OTHER COMMENTS CAN BE PROVIDED AT THIS TIME. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE COMPLAINT PTX STENT WAS PLACED IN RIGHT UPPER SFA, (B)(6) 2013 ALTHOUGH NO SYMPTOMS WERE OBSERVED TO THE PATIENT, RESTENOSIS (50-99%) IN THE LESION WHERE THE COMPLAINT STENT WAS IMPLANTED WAS CONFIRMED, (B)(6) 2013 PTA WAS PERFORMED AGAINST THE RESTENOSIS AND THE CONDITION OF THE PATIENT RECOVERED. NO FURTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750766 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C777372

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention