BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 3547166 · Received November 21, 2013

    Report

    Report Number
    3001845648-2013-00132
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Date of Event
    July 3, 2013
    Report Date
    November 1, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    PMA / PMN Number
    P100022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS MDR REPORTABLE AS STENT FRACTURE WAS CONFIRMED IN THE PROXIMAL PART OF THE STENT APPROX 12 MONTHS AFTER STENT. THERE WERE NO ZILVER PTX DEVICES OF LOT NUMBER C773933 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. ANGIOGRAM IMAGES WERE NOT PROVIDED FOR THIS COMPLAINT. AS NO IMAGES WERE AVAILABLE FOR REVIEW, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. IT MAY BE NOTED THAT FOR ZILVER PTX, THE STENT IS FULLY ENDOTHELIALIZED AFTER APPROXIMATELY 2 MONTHS AND FURTHER NEOINTIMAL COVERAGE IS PROGRESSING. AFTER THIS TIME THERE MAY BE A REDUCED LIKELIHOOD FOR A STENT FRACTURE, HOWEVER AN ACTIVE PATIENT SHOULD CONSIDER MODERATING ANY VIGOROUS EXERCISE AND AVOID KNEE BENDING IN LONG TIME PERIOD. DUE TO LIMITED INFORMATION PROVIDED FOR THIS COMPLAINT A ROOT CAUSE OF HIS STENT FRACTURE CANNOT BE DETERMINED. AS PER INSTRUCTION FOR USE IFU0063-5 STENT STRUT FRACTURE IS NOTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. 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. NO INFORMATION HAS BEEN PROVIDED IN RELATION TO THE PATIENT'S CURRENT CONDITION. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    (B)(6) 2012, 2 PTX STENTS WERE PLACED IN RIGHT SFA. (B)(6) 2013, X-RAY IMAGING CONFIRMED FRACTURE IN PROXIMAL PART OF THE STENT (TYPE 2) UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606565 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIO STENT, ILIAC NIO COOK IRELAND LTD C773933

    Patients

    Seq Age Sex Outcome Treatment
    1