BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 4283364 · Received November 20, 2014

    Report

    Report Number
    3001845648-2014-00250
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002248912
    PMA / PMN Number
    P100022/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZILVER PTX DEVICE INVOLVED IN THIS COMPLAINT IS AS FOLLOWS: ZIV6-35-125-7-40-PTX OF LOT NUMBER C990551 CONTAINING THE ZILVER PTX DRUG ELUTING STENT. THE PTX STENT INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PT AND WAS THEREFORE, NO AVAILABLE FOR EVAL. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES RELATING TO THIS EVENT WERE REQUESTED, BUT HAVE NOT BEEN PROVIDED. THE FOLLOWING INFO WAS PROVIDED IN RELATION TO THIS COMPLAINT. "THE PHYSICIAN DOES NOT KNOW EXACTLY WHEY THE STENTS THROMBOSED BUT DID MENTION THAT THE PT POTENTIALLY MAY HAVE NOT BEEN ADEQUATELY ANTICOAGULATED." DUE TO THE LACK OF IMAGES, NO FURTHER INFO CAN BE PROVIDE AT THIS TIME. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. AS PER THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE, ARTERIAL THROMBOSIS IS NOTED AS A POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. A REVIEW OF THE RELEVANT MFG RECORDS FOR ZILVER DRUG ELUTING STENTS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. AS THE STENT INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVAL AND CONDITION OF USE CANNOT BE REPLICATED IN A LAB SETTING, IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BASED ON THE INFO PROVIDED, NO FURTHER ADVERSE EFFECTS TO THE PT HAVE BEEN REPORTED AS OCCURRING. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE PT HAD TWO ZILVER PTX STENTS IMPLANTED ON (B)(6) 2014. THE IMPLANT PROCEDURE APPEARED TO HAVE GONE WELL AND THE STENTS LOOKED GREAT AT IMPLANT. ON (B)(6) 2014, THE PT CAME BACK TO THE HOSPITAL AS BOTH STENTS WERE ACUTELY THROMBOSED. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2014 WITH A LASER TO OPEN UP THE STENTS. THE PHYSICIAN DOES NOT KNOW EXACTLY WHY THE STENTS THROMBOSED, BUT DID MENTION THAT THE PT POTENTIALLY MAY HAVE NOT BEEN ADEQUATELY ANTICOAGULATED. NO FURTHER ADVERSE EFFECTS TO THE PT HAVE BEEN REPORTED AS OCCURRING. REF ALSO RELATED REPORT 3001845648-2014-00249.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755772 ZILVER PTX 35 DRUG-ELUTING STENT NONE NIU COOK IRELAND LTD C990551 10827002248912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention