BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4254391 · Received November 12, 2014

    Report

    Report Number
    3001845648-2014-00226
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    February 18, 2014
    Report Date
    October 15, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENT MEETS CRITERIA OF AN FDA MDR REPORT BASED ON THE INTERVENTION CARRIED OUT (REMOVAL OF THE BLOOD CLOTS AND STENT PLACEMENT) AS A RESULT OF RESTENOSIS OCCURRING WHILE A ZILVER PTX STENT WAS INDWELLING. THE ZILVER PTX DEVICE INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PT THEREFORE, IS NOT AVAILABLE FOR EVAL. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ADD'L COMMENT RECEIVED FROM THE PHYSICIAN IS AS FOLLOWS: "ALTHOUGH SOME BLOOD CLOTS WERE SEEN IN THE STENOSED PART, SINCE INTIMAL THICKENING WAS ALSO OBSERVED THERE, WE DIAGNOSED THAT IT WAS NOT IN-STENT THROMBOSIS." IT MAY BE NOTED THAT RE-STENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND CAN BE REACHED BY INJURY TO THE VESSEL (E.G. DURING PTA AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THA T LEADS (OR AMPLIFIES) OT THE RESTENOSIS PROCESS. AS PER INSTRUCTIONS FOR USE: WORSENED CLAUDICATION AND RESTENOSIS OF THE STENTED ARTERY ARE NOTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. ALTHOUGH REQUESTED IMAGES WERE NOT AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION. A REVIEW OF THE MFG RECORDS FOR ZIV6-35-125-6.0-40- PTX DEVICE AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. SINCE THERE ARE NO IMAGES AVAILABLE FOR REVIEW, THERE IS NO EVIDENCE TO SUGGEST THAT RE-STENOSIS DID NOT OCCUR; THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE COMPLAINT PRODUCT WAS PLACED IN THE LOWER PART OF THE RIGHT SFA, (B)(6) 2014 RESTENOSIS (50-99%) IN THE LESION WHERE THE COMPLAINT STENT WAS IMPLANTED WAS CONFIRMED. ULCER AND WORSENED CLAUDICATION WAS OBSERVED TO THE PT. REMOVAL OF THE BLOOD CLOTS AND STENT PLACEMENT (MISAGO/ TERUMO) WERE PERFORMED AGAINST THIS. THE CONDITION OF THE PT RECOVERED. NO FURTHER ADVERSE EFFECTS TO THE PT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729574 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG ELUTING NIU COOK IRELAND LTD C772689

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention