BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 5260078 · Received December 2, 2015

    Report

    Report Number
    3001845648-2015-00262
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    October 13, 2015
    Report Date
    November 4, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#:P100022/S001 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 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 HYPERTENSION, HYPERCHOLESTEROLEMIA AND WAS A PREVIOUS SMOKER. ACCORDING TO COMPLAINT INFORMATION PROVIDED, WORSEN CLAUDICATION WAS 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 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 A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. DUE TO LACK OF IMAGING NO OTHER COMMENTS CAN BE MADE. AS NO IMAGING WAS AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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 PROVIDED PTA WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS. PMA/510(K)#: P100022/S001. 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 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 HYPERTENSION, HYPERCHOLESTEROLEMIA AND WAS A PREVIOUS SMOKER. ACCORDING TO COMPLAINT INFORMATION PROVIDED, WORSEN CLAUDICATION WAS 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 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 A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. DUE TO LACK OF IMAGING NO OTHER COMMENTS CAN BE MADE. AS NO IMAGING WAS AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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 PROVIDED PTA WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    (B)(6) 2012: THREE ZILVER PTX WERE IMPLANTED IN THE PATIENT'S RIGHT SFA; ZIV6-35-125-6.0-120-PTX (C780022) / ZIV6-35-125-6.0-120-PTX (C780022) / ZIV6-35-125-6.0-40-PTX (CF766267). DATE UNKNOWN: IT WAS CONFIRMED THAT THE RESTENOSIS (50-99%) WHERE THE PTX WERE IMPLANTED. WORSEN INTERMITTENT CLAUDICATION AND WORSEN RUTHERFORD WERE OBSERVED ON THE PATIENT. (B)(6) 2015: PTA PERFORMED. AS THREE ZILVER PTX DEVICES ARE SUSPECTED TO BE INVOLVED IN THIS EVENT A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE ALSO REPORTS 3001845648-2015-00263 AND 3001845648-2015-00264.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790023 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR