BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING STENT

    MDR report key: 4071556 · Received August 28, 2014

    Report

    Report Number
    3001845648-2014-00158
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    May 20, 2014
    Report Date
    July 31, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS COMPLAINT IS: 1 X ZIV6-35-125-6-40-PTX (LOT NO. C972176). FROM THE INFORMATION PROVIDED, THE DEVICE INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PT AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION. WITH THIS INFORMATION, A DOCUMENTS BASED INVESTIGATION WAS CARRIED OUT. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NO. C972176 OF ZIV6-35-125-6-40-PTX DEVICES REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. AS THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION AND CONDITIONS OF USE CANNOT BE REPLICATED IN THE LABORATORY IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINED THE ROOT CAUSE FOR THIS COMPLAINT. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT IT IS NOT CERTAINLY KNOWN IF THE DEVICE, THE PROCEDURE OR BOTH CONTRIBUTED TO THE REPORTED THROMBOSIS ISSUE. AS PER THE INSTRUCTIONS FOR USE WHICH ACCOMPANIED THIS DEVICE, WORSENED CLAUDICATION / REST PAIN AND ARTERIAL THROMBOSIS ARE NOTED AS POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. IMAGES OF THE EVENT HAVE BEEN RECEIVED AND HAVE BEEN FORWARDED FOR CLINICAL REVIEW. ON RECEIPT OF THE IMAGE REVIEW, ANY RELEVANT ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW UP REPORT. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. BASED ON THE INFORMATION PROVIDED, THE PT WAS DISCHARGED ON THE SAME DAY ((B)(6) 2014) AFTER TREATMENT. NO FURTHER ADVERSE EFFECTS HAVE BEEN REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, TWO ZILVER PTX STENTS WERE PLACED ON A STUDY LESION. FINAL LESION MORPHOLOGY REVEALED THROMBUS WAS PRESENT. NO DISSECTION WAS NOTED AND THE ENTIRE LENGTH OF THE STENT APPOSED TO THE VESSEL WALL. ON THE SAME DAY, THE PT EXPERIENCED EMBOLISM DISTAL TO THE LESION WHICH WAS TREATED WITH THROMBOLYSIS. ON (B)(6) 2014, THE PT EXPERIENCED A THROMBOSIS OF THE STUDY VESSEL. IT IS UNK IF THE STUDY LESION WAS INVOLVED. THE SITE REPORTED THAT THE PT EXHIBITED A RAPID ONSET OF CLINICAL SIGNS AND SYMPTOMS INCLUDING PERSISTENT/WORSENING CLAUDICATION AND REST PAIN. THROMBOSIS WAS IDENTIFIED VIA ANGIOGRAPHY. TREATMENT INCLUDED BALLOON ANGIOPLASTY, THROMBECTOMY, THROMBOLYSIS AND PLACEMENT OF A STENT. THE PHYSICIAN REPORTED THE EVENT WAS "PROBABLY" RELATED TO THE STUDY PRODUCT AND "PROBABLY" RELATED TO THE STUDY PROCEDURE. THE PT WAS DISCHARGED THE SAME DAY. AS PER THE ABOVE COMPLAINT DESCRIPTION EVENTS RECEIVED, TWO DEVICE ARE INVOLVED IN THIS INCIDENT. AN ADDITIONAL SEPARATE REPORT WILL BE SUBMITTED DIN RELATION TO THE OTHER DEVICE REPORTED. REPORT REFERENCE NUMBER: 3001845648-2014-00157. NO FURTHER ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525416 ZILVER PTX DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C972176

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention