BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 3697724 · Received March 6, 2014

    Report

    Report Number
    3001845648-2014-00040
    Event Type
    Injury
    Date Received
    March 6, 2014
    Report Date
    February 5, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE INTERVENTION PERFORMED (ASPIRATION OF BLOOD CLOTS AND POBA) DUE TO THE OCCURRENCE OF THROMBOSIS WHILE ZILVER PTX WAS INDWELLING. THE (B)(6) 2012, THREE PTX STENTS WERE IMPLANTED IN LEFT SFA. ON AN UNK DATE THROMBOSIS WAS CONFIRMED. ASPIRATION OF BLOOD CLOTS AND POBA WERE PERFORMED AGAINST THROMBOSIS AND THE BLOOD FLOW IMPROVED. THE DATE OF THIS ADDITIONAL PROCEDURE IS UNK AT THIS TIME. THE DEVICE INVOLVED IN THIS COMPLAINT IS: 1 X ZIV6-35-125-6.0-120-PTX (LOT NUMBER C780031). DETAILS REGARDING THE TWO OTHER ZILVER PTX STENTS IMPLANTED ON THE (B)(6) 2012 WILL BE SUBMITTED UNDER SEPARATE REPORTS. REFERENCE 3001845648-2014-00041 AND 3001845648-2014-00042. THERE WERE NO ZILVER PTX DEVICES OF THE NUMBERS (B)(4) IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICES WERE NOT AVAILABLE FOR EVAL. THE STENTS WERE IMPLANTED IN THE PT THEREFORE ARE NOT AVAILABLE FOR EVAL. IMAGES WERE REQUESTED BUT HAVE NOT YET BEEN PROVIDED TO REPORT THE COMPLAINT INVESTIGATION. ACCORDING TO THE INFO PROVIDED, THE PT HAD THE FOLLOWING KNOWN POTENTIAL RISKS FACTORS FOR THROMBOSIS: CANCER, HYPERLIPIDEMIA, HYPERTENSION, TYPE 2 DIABETES, MODERATE/SEVERE CALCIFICATION, ADVANCED AGE ((B)(6)) AND WAS AN EX-SMOKER. BASED ON THE ABOVE, IT MAY BE NOTED THAT THE PT HAD A NUMBER OF RISK FACTORS THAT COULD HAVE CONTRIBUTED TO THE THROMBOSIS EVENT. IT IS UNLIKELY THAT THROMBOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION HOWEVER, A DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. DUE TO THE LACK OF IMAGES, NO OTHER COMMENTS CAN BE PROVIDED HOWEVER, IT SHOULD BE NOTED THAT PHYSICIAN INVOLVED STATED "I GUESS THAT THROMBOSIS OCCURS TO THIS PT EASILY AS HE HAS LEUKEMIA. THEREFORE, I DO NOT THINK THIS EVENT WAS CAUSED DUE TO THE DEVICE MALFUNCTION." A FOLLOW UP EXAM CONDUCTED ON THE (B)(6) 2014 CONFIRMED NO FURTHER ADVERSE EFFECTS TO THE PT WERE OBSERVED. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. AS PER INSTRUCTION FOR USE IFU0063-5 THROMBOSIS IS NOTED AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. SINCE THERE ARE NO IMAGES AVAILABLE FOR REVIEW, THERE IS NO EVIDENCE TO SUGGEST THAT THROMBOSIS DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK WAS ASSESSED FOR THE COMPLAINT AND WAS DETERMINED TO BE MODERATE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON THE (B)(6) 2012, THREE ZILVER PTX STENTS WERE IMPLANTED IN THE LEFT SFA. ON UNK DATE, THROMBOSIS WAS CONFIRMED. ON THE (B)(6) 2014 ASPIRATION OF THE BLOOD CLOTS AND POBA WERE PERFORMED BY RIGHT CFA CONTRALATERAL APPROACH AND THE BLOOD FLOW IMPROVED. THE PT RECOVERED AND A FOLLOW UP EXAM CONDUCTED ON THE (B)(6) 2014 CONFIRMED NO FURTHER ADVERSE EFFECTS TO THE PT WERE OBSERVED. PLEASE NOTE A FURTHER TWO SEPARATE REPORTS WILL BE SUBMITTED IN RELATION TO THE ADDITIONAL ZILVER PTX DEVICES INVOLVED IN THE COMPLAINT. REFERENCE MDR REPORTS 3001845648-2014-00041 AND 3001845648-2014-00042.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137963 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU COATED SELF EXPANDING VASCULAR STENTS NIU COOK IRELAND LTD C780031

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention