BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 5587065 · Received April 19, 2016

    Report

    Report Number
    3001845648-2016-00110
    Event Type
    Injury
    Date Received
    April 19, 2016
    Date of Event
    January 22, 2015
    Report Date
    March 22, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002513454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022/S001. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C781428 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT WAS CONFIRMED THAT IMAGES WOULD NOT BE AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION. AVAILABLE INFORMATION STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING CORONARY ARTERY DISEASE, HYPERTENSION AND HYPERCHOLESTEROLEMIA. IN ADDITION WORSEN CLAUDICATION AND WORSEN RUTHERFORD WERE ALSO OBSERVED ON THE PATIENT. IT CAN BE NOTED THAT WORSEN CLAUDICATION INDICATES PROGRESSION OF PERIPHERAL ARTERY DISEASE AND CAN ALSO BE ASSOCIATED WITH THE RESTENOSIS PROCESS. 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 MAY BE NOTED THAT THE SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG PACLITAXEL TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. BASED ON THE ABOVE IT IS VERY UNLIKELY THAT THE REPORTED RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION, HOWEVER A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. DUE TO LACK OF IMAGING NO OTHER COMMENTS CAN BE MADE. IT MAY BE NOTED THAT WORSENED CLAUDICATION AND RESTENOSIS OF THE STENTED ARTERY ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH 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 BYPASS SURGERY WAS PERFORMED AND THE PATIENT HAD A FAVOURABLE OUTCOME. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012: ZILVER PTX X 3 WERE PLACED IN THE LEFT SFA. ON (B)(6) 2015: 100%-RESTENOSIS IN THE LESION WAS CONFIRMED. (THE RPN OR LOT NUMBER OF THE RE-STENOSED DEVICE(S) CANNOT BE DETERMINED) "WORSEN RUTHERFORD" AND "WORSEN CLAUDICATION" WERE OBSERVED. DATE UNKNOWN (BECAUSE THE INFORMATION WAS PROVIDED BY ANOTHER HOSPITAL): BYPASS SURGERY WAS PERFORMED. THE PATIENT HAD A FAVOURABLE OUTCOME. AS THREE ZILVER PTX STENTS ARE REPORTED AS INVOLVED IN THIS EVENT, A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE ALSO REPORTS # 3001845648-2016-00111 AND 3001845648-2016-00112.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241916 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002513454

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention