BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 6215317 · Received December 30, 2016

    Report

    Report Number
    3001845648-2016-00400
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    October 12, 2016
    Report Date
    January 19, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002513454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # P100022/S001. FROM THE COMPLAINT INFORMATION PROVIDED, IT IS KNOWN THAT 1 RESTENOSIS EVENT OCCURRED, INVOLVING 3 ZILVER PTX STENTS. THIS COMPLAINT FILE ADDRESSES 2X ZIV6-35-125-6.0-120-PTX OF LOT NUMBER C780022. FOR THE INVESTIGATION STATUS OF THE ZIV6-35-125-6.0-40-PTX DEVICE OF LOT NUMBER CF766267 REFER TO 3001845648-2016-00401. THE ZIV6-35-125-6.0-120-PTX OF LOT NUMBER C780022 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THERE IS NO IMAGING AVAILABLE TO SUPPORT THIS INVESTIGATION. ACCORDING TO THE INFORMATION PROVIDED, RESTENOSIS WAS CONFIRMED AT THE LESION WHERE THE DEVICE WAS PLACED. AVAILABLE INFORMATION STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING: HYPERTENSION, HYPERCHOLESTEROLEMIA, RENAL FAILURE, SMOKED. 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. 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. 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, A DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT AS PER THE PACKAGE INSERT, RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. ADDITIONALLY WORSENED CLAUDICATION IS ALSO AN ADVERSE EFFECT. 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 OCCURRED PREVIOUSLY WITH THE LOT NUMBER. HOWEVER, BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER. ACCORDING TO THE INFORMATION PROVIDED, RESTENOSIS WAS CONFIRMED AT THE LESION WHERE THE DEVICE WAS PLACED. PTA WAS THEN PERFORMED & THE PATIENT RECOVERED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # P100022/S001. FROM THE COMPLAINT INFORMATION PROVIDED, IT IS KNOWN THAT 1 RESTENOSIS EVENT OCCURRED, INVOLVING 3 ZILVER PTX STENTS. THIS COMPLAINT FILE ADDRESSES 2X ZIV6-35-125-6.0-120-PTX OF LOT NUMBER C780022. FOR THE INVESTIGATION STATUS OF THE ZIV6-35-125-6.0-40-PTX DEVICE OF LOT NUMBER CF766267 REFER TO (B)(4). THE ZIV6-35-125-6.0-120-PTX OF LOT NUMBER C780022 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THERE IS NO IMAGING AVAILABLE TO SUPPORT THIS INVESTIGATION. ACCORDING TO THE INFORMATION PROVIDED, RESTENOSIS WAS CONFIRMED AT THE LESION WHERE THE DEVICE WAS PLACED. AVAILABLE INFORMATION STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING: HYPERTENSION, HYPERCHOLESTEROLEMIA, RENAL FAILURE, SMOKED. 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. AS PER THE INFORMATION PROVIDED ON THE 21-DEC-2016, IT WAS CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION. 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. 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, A DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT AS PER THE PACKAGE INSERT, RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. ADDITIONALLY WORSENED CLAUDICATION IS ALSO AN ADVERSE EFFECT. 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 OCCURRED PREVIOUSLY WITH THE LOT NUMBER. HOWEVER, BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER. ACCORDING TO THE INFORMATION PROVIDED, RESTENOSIS WAS CONFIRMED AT THE LESION WHERE THE DEVICE WAS PLACED. PTA WAS THEN PERFORMED AND THE PATIENT RECOVERED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012: THREE PTX STENTS WERE PLACED IN THE RIGHT SFA. DATE UNKNOWN: 100% RESTENOSIS WAS CONFIRMED IN THE RIGHT SFA. "WORSEN CLAUDICATION" WAS OBSERVED. ON (B)(6) 2016: PTA WAS PERFORMED. ON (B)(6) 2016: THE PATIENT RECOVERED. IT WAS CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION. REFERENCE ALSO REPORT # 3001845648-2016-00401.

    Description of Event or Problem · 1

    A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE NEW INFORMATION IN RELATION TO THE EVENT DATE AND PATIENT RECOVERY DATE. INITIAL REPORT DETAILS: (B)(6) 2012: THREE PTX STENTS WERE PLACED IN THE RIGHT SFA. DATE UNKNOWN: 100% RESTENOSIS WAS CONFIRMED IN THE RIGHT SFA. "WORSEN CLAUDICATION" WAS OBSERVED. ON (B)(6) 2016: PTA WAS PERFORMED. ON (B)(6) 2016: THE PATIENT RECOVERED. UPDATED INFORMATION RECEIVED AS FOLLOWS: (B)(6) 2012: THREE PTX STENTS WERE PLACED IN THE RIGHT SFA. ON (B)(6) 2016: 100% RESTENOSIS WAS CONFIRMED IN THE RIGHT SFA. "WORSEN CLAUDICATION" WAS OBSERVED. ON (B)(6) 2016: PTA WAS PERFORMED. ON (B)(6) 2016 : THE PATIENT RECOVERED. IT WAS CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION. REFERENCE ALSO REPORT # 3001845648-2016-00401.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866651 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 Required Intervention