BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 7036336 · Received November 16, 2017

    Report

    Report Number
    3001845648-2017-00545
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 19, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002513454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PMA/510(K) # P050017/S002 AND S003. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C777743 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT WAS STATED BY THE ORIGINATOR IN THE COMPLAINT FILE THAT THERE ARE NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT HAD THE FOLLOWING PRE-EXISTING CONDITIONS AT THE TIME OF THE PROCEDURE: CORONARY ARTERY DISEASE, HYPERTENSION, DIABETES(TYPE2), HYPERCHOLESTEROLEMIA 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS TO (OR AMPLIFIES) THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG (PACLITAXEL) TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. IT CAN BE THEREFORE STATED THAT IT IS VERY UNLIKELY THAT THE REPORTED RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER AS NO IMAGING WAS AVAILABLE AT THE TIME OF INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THIS TIME. IN ADDITION WORSENED CLAUDICATION WAS ALSO OBSERVED 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. IT MAY BE NOTED THAT THE PACKAGING INSERT LISTS RESTENOSIS OF THE STENTED ARTERY AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH PLACEMENT OF THIS DEVICE. WORSENED CLAUDICATION IS ALSO LISTED AS A POTENTIAL ADVERSE EVENT IN THE PACKAGING INSERT FOLLOWING 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. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THE LOT NUMBER C777743. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C777743. TREATMENT WITH CUTTING BALLOON WAS CONDUCTED AGAINST THIS STENOSIS ON THE SAME DAY AND THE PATIENT'S CONDITION WAS RECOVERED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR ANY POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ON (B)(6) 2012 - A PTX STENT WAS PLACED IN THE LEFT SFA OF A MALE PATIENT. ON (B)(6) 2017 RESTENOSIS IN THE STENTED LESION WAS CONFIRMED. WORSENED INTERMITTENT CLAUDICATION WAS OBSERVED ON THE PATIENT. TREATMENT WITH CUTTING BALLOON WAS CONDUCTED AGAINST THIS STENOSIS ON THE SAME DAY AND THE PATIENT'S CONDITION WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817971 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIO STENT, ILIAC NIO COOK IRELAND LTD 10827002513454

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention