BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4254400 · Received November 12, 2014

    Report

    Report Number
    3001845648-2014-00227
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    August 14, 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 REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE SURGICAL INTERVENTION CARRIED OUT 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: "THE CAUSE OF RESTENOSIS IS UNK SINCE LONG TIME HAS PASSED". IMAGES WERE NOT AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION. IT MAY BE NOTED THAT RE-STENOSIS 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 (OR AMPLIFIES) TO THE RESTENOSIS PROCESS. AS THE INSTRUCTIONS FOR USE, RESTENOSIS OF THE STENTED ARTERY IS NOTED AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. A REVIEW OF THE RELEVANT MFG RECORDS REVEALED NO DISCREPANCIES RELATED TO THIS COMPLAINT ISSUE. 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

    (B)(6) 2012, THE DEVICE WAS PLACED IN THE RIGHT DISTAL SFA. (B)(6) 2014, RESTENOSIS WAS CONFIRMED. (B)(6) 2014, RESTENOSIS WAS TREATED WITH A CUTTING BALLOON. 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
    729628 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C777374

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention