BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4287702 · Received November 24, 2014

    Report

    Report Number
    3001845648-2014-00262
    Event Type
    Injury
    Date Received
    November 24, 2014
    Date of Event
    April 25, 2013
    Report Date
    October 27, 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). THIS INVESTIGATION ADDRESSES 1X ZIV6-35-125-6.0-120-PTX OF LOT C780022. REFERENCE ALSO DIRECTLY RELATED TO MDR REPORTS 3001845648-2014-00260 AND 3001845648-2014-00261. NOTE STENT FRACTURES HAVE ALSO BEEN REPORTED IN THE REFERENCED DEVICES OCCURRING ON (B)(6) 2014. REFERENCE MDR REPORTS 3001845648-2014-00263 AND 3001845648-2014-00264. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C780022 WAS IMPLANTED IN THE PATIENT; THEREFORE, IS NOT AVAILABLE FOR EVALUATION. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ANGIOGRAPHY IMAGES FROM STENT IMPLANTATION ((B)(6) 2012) AND F/U RUNOFF ((B)(6) 2013) WERE PROVIDED. IN RELATION TO THE REPORTED RESTENOSIS THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: "...DUE TO OVERLAPPING PROFUNDA FEMORAL ARTERY BRANCHES, A STENOSIS IN THE PROXIMAL SFA STENT AT THE SFA ORIGIN WAS INADEQUATELY IMAGED HOWEVER, DESPITE THIS, A STENOSIS FROM NEO-INTIMAL HYPERPLASIA WAS PRESENT. IT CAUSED APPROX 80% MAXIMAL DIAMETER STENOSIS WITH A RESIDUAL LUMINAL DIAMETER APPROX 1.3MM. DISTAL TO THIS NEO-INTIMAL HYPERPLASIA NARROWED THE PROXIMAL STENT 60% MAXIMAL DIAMETER STENOSIS WITH A RESIDUAL LUMINAL DIAMETER OF 2.5MM. THE MID-SFA STENT WAS NARROWED BY NEO-INTIMAL HYPERPLASIA 50%, RESIDUAL LUMINAL DIAMETER OF 3MM, JUST PROXIMAL A NEW MID-STENT 1MM STEP OFF. NEO INITIAL HYPERPLASIA IN THE DISTAL PORTION OF THE STENT CAUSED 40% MAXIMAL DIAMETER STENOSIS. NEO-INTIMAL HYPERPLASIA IN THE DISTAL STENT RESULTED IN 20% MAXIMAL DIAMETER STENOSIS. NO INFLOW LIMITATION WAS PRESENT. ...NEO-INTIMAL HYPERPLASIA WAS PRESENT IN ALL THREE STENTS. IT RESULTED IN PROXIMAL STENT SEVER STENOSIS, MID-STENT MODERATE STENOSIS, AND DISTAL STENT MILD STENOSIS. ...RUNOFF WAS POOR, POOR RUNOFF IS A RISK FACTOR FOR BARE METAL AND PTFE COVERED STENT STENOSIS AND POSSIBLY WAS A FACTOR IN THIS CASE (J VASC. SURG. 2008 MAY; 47(5): 967-74.)". BASED ON THE IMAGES. THE CUSTOMER COMPLAINT WAS CONFIRMED. 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. BASED ON THE FEEDBACK PROVIDED BY THE INDEPENDENT IMAGE REVIEWER, NEO-INTIMAL HYPERPLASIA WAS PRESENT IN ALL THREE STENTS WHICH RESULTED IN STENT RESTENOSIS. POOR RUNOFF IS A RISK FACTOR FOR STENT STENOSIS AND IT IS POSSIBLE THAT THIS COULD ALSO BE A CONTRIBUTING FACTOR IN THIS CASE. HOWEVER, A DEFINITIVE ROOT CAUSE OF THIS STENT RESTENOSIS CANNOT BE DETERMINED. RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT 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. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A ZIV6-35-125-6.0-120-PTX, ZIV6-35-125-6.0-40-PTX, AND ZIV6-35-125-6.0-120-PTX WERE PLACED IN THE RIGHT SFA (FROM PROXIMAL SIDE; ZIV6-35-125-6.0-40-PTX, ZIV6-35-125-6.0-120-PTX, ZIV6-35-125-6.0-120-PTX), ON (B)(6) 2014 RESTENOSIS WAS CONFIRMED. (RESTENOSED STENT CANNOT BE CONFIRMED), ON (B)(6) 2014: PTA WAS PERFORMED, (B)(6) 2014: THE PATIENT HAD FAVOURABLE OUTCOME. NO FURTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762021 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 74 YR Required Intervention