BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4777059 · Received May 15, 2015

    Report

    Report Number
    3001845648-2015-00096
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    October 23, 2013
    Report Date
    April 17, 2015
    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

    PMA/510(K)#: P100022 AND S001. UDI#: (B)(4). THIS INVESTIGATION ADDRESSES RESTENOSIS OF THE LESION WHERE 1 X ZIV6-35-125-6.0-120-PTX OF LOT C781428 WAS IMPLANTED. THE STENT REMAINS IMPLANTED IN THE PATIENT. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ACCORDING TO COMPLAINT INFORMATION PROVIDED, WORSENED RUTHERFORD, WORSENED CLAUDICATION AND REST PAIN WERE OBSERVED ON THE PATIENT. THE EXACT STAGE OF RUTHERFORD CLASSIFICATION IS UNKNOWN, BUT WORSENED CLAUDICATION AND REST PAIN INCLUDES PROGRESSION OF PERIPHERAL ARTERY DISEASE AND CAN 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 SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG (PACLITAXEL) TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. IT CAN BE THEREFORE STATED THAT 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. AS NO IMAGING WAS AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT RESTENOSIS OF THE STENTED ARTERY AND WORSENED CLAUDICATION/REST PAIN ARE KNOWN POTENTIAL ADVERSE EVENTS 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. ACCORDING TO INFORMATION PROVIDED, BYPASS SURGERY WAS PERFORMED AGAINST THE RESTENOSIS AND THE PATIENT'S CONDITION IMPROVED. 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 WERE PLACED IN THE RIGHT SFA OF A (B)(6) PATIENT. ON (B)(6) 2013, 100% RESTENOSIS OF THE LESION WHERE THE STENTS WERE PLACED (CONCRETELY WHERE IN THE THREE STENT: UNKNOWN). WORSENED CLAUDICATION, WORSENED RUTHERFORD AND REST PAIN WERE OBSERVED ON THE PATIENT. ON (B)(6) 2014, BYPASS SURGERY WAS PERFORMED AGAINST THE RESTENOSIS. ON (B)(6) 2014, THE CONDITION OF THE PATIENT IMPROVED. THIS REPORT ADDRESSES THE SECOND DEVICE REPORTED. TWO ADDITIONAL SEPARATE REPORTS WILL BE SUBMITTED IN RELATION TO THE FIRST AND THIRD DEVICE REPORTED. REPORT REFERENCE NUMBER 3001845648-2015-00095 AND 3001845648-2015-00097.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317946 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C781428

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention