BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 5949198 · Received September 14, 2016

    Report

    Report Number
    3001845648-2016-00242
    Event Type
    Injury
    Date Received
    September 14, 2016
    Date of Event
    March 7, 2016
    Report Date
    August 18, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002513454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022/S001. THIS PR CAPTURES THE INTERVENTION CONDUCTED ON 7 MAR 2016. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C780031 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. FROM AVAILABLE INFORMATION, IT IS KNOWN THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING; HYPERCHOLESTEROLEMIA AND DIABETES TYPE I. IN ADDITION, WORSENED CLAUDICATION WAS SEEN 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. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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 C780031. ACCORDING TO INFORMATION PROVIDED PTA WAS PERFORMED AGAINST THE RESTENOSIS AND 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: ZIV6-35-125-6.0-120-PTX (C780031) AND ZIV6-35-125-6.0-60-PTX (C781079) WERE PLACED ON THE PATIENT'S RIGHT SFA. ON (B)(6) 2016 - [3001845648-2016-00242/3001845648-2016-00243]: IT WAS CONFIRMED THAT THE RESTENOSIS (100%) ON THE LESION WHERE THE STENTS WERE PLACED. WORSEN CLAUDICATION WAS SEEN ON THE PATIENT. PTA WAS PERFORMED AGAINST RESTENOSIS. THE PATIENT CONDITION RECOVERED. ON (B)(6) 2016 - [3001845648-2016-00243/ 3001845648-2016-00244]: IT WAS CONFIRMED THAT THE RESTENOSIS (100%) ON THE LESION WHERE THE STENTS WERE PLACED. WORSEN CLAUDICATION WAS SEEN ON THE PATIENT. PTA WAS PERFORMED AGAINST RESTENOSIS. THE PATIENT CONDITION RECOVERED. ON (B)(6) 2016 - [3001845648-2016-00246/ 3001845648-2016-00247]: IT WAS CONFIRMED THAT THE RESTENOSIS (100%) ON THE LESION WHERE THE STENTS WERE PLACED. WORSEN CLAUDICATION WAS SEEN ON THE PATIENT. PTA WAS PERFORMED AGAINST RESTENOSIS. THE PATIENT CONDITION RECOVERED. AS TWO SUSPECT DEVICES ARE INVOLVED WITH SEPARATE EVENTS OCCURRING; A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH DEVICE AND EVENT DATE (REPORT REFERENCE NUMBERS INCLUDED IN ABOVE DESCRIPTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600033 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 76 YR Required Intervention