BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4553450 · Received February 24, 2015

    Report

    Report Number
    3001845648-2015-00035
    Event Type
    Injury
    Date Received
    February 24, 2015
    Date of Event
    April 21, 2014
    Report Date
    January 26, 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/510K: P100022 AND S001. (B)(4). THE ZIV6-35-125-6.0-120-PTX DEVICE OF LOT C780022 WAS IMPLANTED IN THE PT AND IS THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT MAY BE NOTED THAT 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 IS VERY UNLIKELY THAT THE REPORTED EVENT COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. ACCORDING TO INFORMATION PROVIDED, IMAGES ARE UNAVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION. AS NO IMAGING WAS AVAILABLE; NO OTHER COMMENTS CAN BE MADE. THERE IS NO EVIDENCE TO SUGGEST THAT RESTENOSIS DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT REST PAIN AND RESTENOSIS OF STENTED ARTERY ARE KNOWN 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 RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ACCORDING TO INFORMATION PROVIDED, PTA WAS PERFORMED AGAINST RESTENOSIS AND THERE HAVE BEEN NO FURTHER ADVERSE EFFECTS TO THE PT. 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 X 3 WERE PLACED IN THE RIGHT SFA AND RIGHT POPA TO THE PT. ON (B)(6) 2014: RESTENOSIS WHERE THE STENTS WERE PLACED WAS CONFIRMED. REST PAIN WAS OBSERVED ON THE PT. (B)(6) 2104: PTA WAS PERFORMED AGAINST RESTENOSIS. (B)(6) 2014: THERE HAVE BEEN NO FURTHER ADVERSE EFFECTS TO THE PT. AS 3 ZILVER PTX DEVICES ARE INVOLVED IN THE EVENT, THREE SEPARATE MDR REPORTS HAVE BEEN SUBMITTED. REFERENCE ALSO REPORT REF #: 3001845648-2015-00034, 00033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127595 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C780022

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention