BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 3597022 · Received January 21, 2014

    Report

    Report Number
    3001845648-2014-00008
    Event Type
    Injury
    Date Received
    January 21, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 20, 2013
    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

    ON (B)(6) 2013, 4 ZILVER PTX STENTS WERE PLACED IN THE SFA BY RIGHT FEMORAL APPROACH. ON (B)(6) 2013, A DECREASE IN ABI SCORE WAS OBSERVED. THE LESION WAS CHECKED BY ANGIOGRAPHY, WHICH CONFIRMED OCCLUSION WITHIN ALL THE 4 PTX STENTS. A MISAGO STENT AND A SMART STENT WERE PLACED IN THE OCCLUDED AREA WHILE COVERING ALL THE 4 PTX STENTS FULLY. SMART STENT WAS PLACED IN THE AREA FROM BEGINNING OF SFA TO NEAR SIDE OF THE ADDUCTOR HIATUS. MISAGO STENT WAS PLACED IN THE AREA FROM ADDUCTOR HIATUS TO NEAR SIDE OF POPLITEAL ARTERY. THE DEVICES INVOLVED IN THIS COMPLAINT ARE: 1 X ZIV6-25-125-6.0-60-PTX (LOT NUMBER C925071) AND 3 X ZIV6-35-125-6.0-100-PTX (LOT NUMBERS C922229, C927929 AND C922891). THERE WERE NO ZILVER PTX DEVICES OF LOT NUMBERS C925071, C922229, C927929 OR C922891 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. THE STENTS WERE IMPLANTED IN THE PATIENT THEREFORE ARE NOT AVAILABLE FOR EVALUATION. IMAGES WERE REQUESTED BUT HAVE NOT YET BEEN PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. ACCORDING TO THROMBOSIS QUESTIONNAIRE THE PATIENT HAD KNOWN POTENTIAL RISK FACTORS FOR THROMBOSIS: HYPERLIPIDEMIA, HYPERTENSION, UNCONTROLLED DIABETES AND WAS A SMOKER. IN ADDITION, RESIDUAL OUTFLOW WAS EVIDENT WHICH IS ALSO CONSIDERED A CONTRIBUTING FACTOR TO THROMBOSIS. THE LESION WAS TOTALLY OCCLUDED PRIOR TO STENT PLACEMENT. IN ADDITION, THE PATIENT HAD BEEN ADMINISTERED THE FOLLOWING DRUG TREATMENTS; ASPIRIN AND CLOPIDOGREL. BASED ON THE ABOVE, IT MAY BE NOTED THAT THE PATIENT HAD A NUMBER OF RISK FACTORS (PATIENT/PROCEDURE) THAT COULD HAVE CONTRIBUTED TO THE THROMBOSIS EVENT. IT IS VERY UNLIKELY THAT THROMBOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION HOWEVER A DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT (LOT NUMBERS SPECIFIED ABOVE) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. AS PER THE INSTRUCTIONS FOR USE FOR THIS DEVICE, THROMBOSIS IS NOTED AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THE DEVICE. SINCE THE DEVICE WAS NOT RETURNED OR THERE ARE NO IMAGES AVAILABLE FOR REVIEW, THERE IS NO EVIDENCE TO SUGGEST THAT THROMBOSIS DID NOT OCCUR; THEREFORE THE COMPLAINT CAN BE CONFIRMED. NO CORRECTIVE ACTION IS WARRANTED AS A RESULT OF THIS OCCURRENCE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. IN ADDITION THE PATIENT HAD PRE-EXISTING CONDITIONS AS STATED ABOVE WHICH COULD HAVE CONTRIBUTED TO THE OCCURRENCE OF THROMBOSIS. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    (B)(6) 2013, A ZIV6-35-125-6.0-60-PTX STENT AND THREE ZIV6-35-125-6.2-100-PTX STENTS WERE PLACED IN SFA (IN WHICH SIDE: UNKNOWN) BY RIGHT FEMORAL APPROACH. ON THE (B)(6) 2013, ACUTE THROMBOTIC OCCLUSION WAS CONFIRMED. A SMART STENT WAS PLACED AGAINST IT. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: AS DECREASE IN ABI SCORE WAS OBSERVED, THE LESION WAS CHECKED BY ANGIOGRAPHY, WHICH CONFIRMED OCCLUSION WITHIN ALL THE 4 PTX STENTS. A MISAGO STENT AND A SMART STENT WAS PLACED IN THE OCCLUDED AREA WHILE COVERING ALL THE 4 PTX STENTS FULLY. SMART STENT WAS PLACED IN THE ARA FROM BEGINNING OF SFA TO NEAR SIDE OF THE ADDUCTOR HIATUS. MISAGO STENT WAS PLACED IN THE AREA FROM ADDUCTOR HIATUS TO NEAR SIDE OF POPLITEAL ARTERY. PLEASE BE ADVISED THAT ZIV6-35-125-6.0-60-PTX IS THE SAME DEVICE AS ZIV6-35-125-6-60-PTX WHICH IS REGISTERED FOR SALE IN THE US, ZIV6-35-125-6.0-100-PTX ALSO INVOLVED IN THIS EVENT IS NOT REGISTERED FOR SALE IN THE US. THIS REPORT IS BEING SUBMITTED IN RELATION TO THE ZIV6-35-125-6.0-60-PTX/ZIV6-35-125-6-60-PTX DEVICE ONLY. THE PATIENT INVOLVED HAD AN ADDITIONAL MISAGO AND SMART STENT PLACED IN THE OCCLUDED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50843 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU COATED SELF EXPANDING VASCULAR STENTS NIU COOK IRELAND LTD C925071

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention