BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 6063637 · Received October 28, 2016

    Report

    Report Number
    3001845648-2016-00314
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    May 31, 2016
    Report Date
    October 3, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002513454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022/S001. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C793668 WAS IMPLANTED IN THE PATIENT AND IS UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT WAS CONFIRMED THAT IMAGES WOULD NOT BE AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION. ACCORDING TO INFORMATION PROVIDED, 100% RESTENOSIS WAS CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT IS KNOWN THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING CAROTID ARTERY DISEASE, HYPERTENSION, DIABETES AND HYPERCHOLESTEROLEMIA. IN ADDITION WORSENED CLAUDICATION WAS ALSO OBSERVED ON THE PATIENT. IT CAN BE NOTED THAT THIS SYMPTOM INDICATES PROGRESSION OF PERIPHERAL ARTERY DISEASE AND CAN ALSO BE ASSOCIATED WITH THE RESTENOSIS PROCESS. 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 TO OR AMPLIFIES THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT THE SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG PACLITAXEL TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. BASED ON THE ABOVE, IT IS VERY UNLIKELY THAT THE REPORTED RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. DUE TO LACK OF IMAGING NO OTHER COMMENTS CAN BE MADE. IT MAY BE NOTED THAT RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH 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 RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. HOWEVER, BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C793668. ACCORDING TO INFORMATION PROVIDED PTA WAS PERFORMED AGAINST THE RESTENOSIS AND THE CONDITION OF 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) 2012 THREE PTX STENTS BELOW WERE PLACED IN THE RIGHT SFA OF A MALE PATIENT. ZIV6-35-125-6.0-120-PTX C793668, ZIV6-35-125-6.0-120-PTX C777372, ZIV6-35-125-6.0-40-PTX C771050. ON (B)(6) 2016 100% RESTENOSIS OF THE LESION WAS CONFIRMED. WORSENED CLAUDICATION WAS OBSERVED ON THE PATIENT. PTA WAS PERFORMED AGAINST THIS ISSUE ON THE SAME DAY AND THE CONDITION OF THE PATIENT RECOVERED. REFERENCE ALSO RELATED REPORTS 3001845648-2016-00315 AND 3001845648-2016-00316.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715630 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002513454

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention