BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 3357463 · Received September 11, 2013

    Report

    Report Number
    3001845648-2013-00090
    Event Type
    Injury
    Date Received
    September 11, 2013
    Report Date
    August 14, 2013
    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

    THERE WERE NO ZILVER PTX DEVICES OF LOT NUMBER C771051 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE WAS NOT AVAILABLE FOR EVAL. THE STENT WAS IMPLANTED IN THE PT THEREFORE IS NOT AVAILABLE FOR EVAL. ANGIOGRAM IMAGES WERE PLANNED TO BE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION, HOWEVER, NO IMAGES WERE RECEIVED TO DATE. AS NO IMAGES WERE AVAILABLE FOR REVIEW, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. DUAL ANTIPLATELET THERAPY IS RECOMMENDED TO IMPROVE THE OUTCOME OF THE PTS UNDERGOING STENTING. INFO RECEIVED INDICATED THAT THE PT WAS NOT ADMINISTERED ANY ANTIPLATELET THERAPY PRIOR TO/AFTER THE STENTS HAD BEEN IMPLANTED. IT IS KNOWN THAT THE MAIN COMPLICATIONS AFTER STENT IMPLANTATION ARE IN-STENT RESTENOSIS AND STENT THROMBOSIS. IN THIS CASE, IT HAS BEEN CONFIRMED THAT RESTENOSIS DID NOT OCCUR DUE TO THROMBOSIS. MOREOVER, RE-STENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND IS MORE RELATED TO THE PROCEDURE ITSELF RATHER THAN DEVICE MALFUNCTION. THE ROOT CAUSE OF RESTENOSIS CANNOT BE DETERMINED. AS PER INSTRUCTION FOR USE IFU0063-5 RESTENOSIS OF THE STENTED ARTERY IS NOTED AS A POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. IT HAS BEEN REPORTED THAT THE PT HAD A FAVOURABLE OUTCOME AFTER PTA ON THE (B)(6) 2013. QUALITY ENGINEERING ASSESSED THE COMPLAINT USING THE HEALTH RISK ASSESSMENT SCALE AND THE RISK HAS BEEN DETERMINED TO BE MODERATE. CUSTOMER QA WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, 3 ZILVER PTX STENTS WERE PLACED IN THE LEFT SFA. BEFORE (B)(6) 2013, IN-STENT RESTENOSIS WAS CONFIRMED. ON (B)(6) 2013, PTA WAS PERFORMED. ON (B)(6) 2013, THE PT HAS A FAVOURABLE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455586 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU COATED SELF EXPANDING VASCULAR STENTS NIU COOK IRELAND LTD C771051

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R