BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 2980520 · Received February 21, 2013

    Report

    Report Number
    3001845648-2013-00021
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 24, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFORMATION: COMMON DEVICE NAME: COATED SELF EXPANDING VASCULAR STENTS. PMA NUMBER: P100022. THERE WERE NO ZILVER PTX DEVICES OF LOT NUMBER C777742 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE STENT WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. IMAGES RELATED TO THIS INCIDENT HAVE BEEN REQUESTED AND ARE NOT AVAILABLE . AS THE DEVICE HAS NOT BEEN RECEIVED; THEREFORE THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED THERE IS NO INFORMATION AVAILABLE IN RELATION TO PATIENT'S PRE-EXISTING CONDITIONS, THEREFORE IT CANNOT BE DETERMINED IF THE PATIENT HAD ANY OTHER POTENTIAL RISK FACTOR FOR THROMBOSIS. THAT MIGHT BE ALSO ANATOMICAL FACTORS INVOLVED THAT COULD HAVE CONTRIBUTED TO THIS EVENT, HOWEVER NO INFORMATION WAS PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS FOR ZIV6-35-125-6.0-60-PTX DEVICE OF LOT NUMBER C777742 AND ZVSP6-125-6.0-60-IS (ZILVER PTX DRUG ELUTING STENT) OF LOT NUMBERS CH755400 AND CH762435 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. A LETTER WAS SENT TO (B)(6) PHYSICIANS ON THE (B)(4) 2012 IN RELATION TO STENT THROMBOSIS RECOMMENDING DUAL ANTIPLATELET THERAPY (DAPT) AND REQUEST TO CONDUCT VASCULAR ULTRASOUND 3-MONTHS AFTER DEVICE PLACEMENT. THERE IS NO INFORMATION PROVIDED AS TO WHAT MEDICATION THE PATIENT IS BEING ADMINISTERED. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EFFECT AS PER IFU. HEATH RISK ASSESSMENT WAS INITIATED FOR STENT THROMBOSIS AND THE RISK IS DEEMED TO BE LOW. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED FOR A TREATMENT OF ISR WITH A CONTRALATERAL APPROACH FROM THE RIGHT FEMORAL ARTERY; SMART SENT (CORDIS) HAD BEEN PLACED IN THE LEFT SFA AND STENOSIS WAS CONFIRMED. (THE NUMBER OF THE SMART STENT IS UNKNOWN.) ON (B)(6) 2013, PROMINENT (TOKAI MEDICAL) AND CRUISE (ST. JUDE MEDICAL) WERE ADVANCED FROM THE RIGHT FA AND PASSED THROUGH THE STENOSED SITE IN THE SMART STENT, THEN PRE-DILATION WAS PERFORMED WITH CUTTING BALLOON (BSJ). AFTER THAT, THREE PTX STENTS WERE PLACED IN THE LEFT SFA - ZIV6-35-125-7.0-120-PTX, ZIV6-35-125-7.0-60-PTX AND ZIV6-35-125-6.0-60-PTX WITH NO OVERLAP. POST-DILATION WAS PERFORMED WITH "GENETY" AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2013, STENT THROMBOSIS WAS CONFIRMED. THEN, THROMBUS ASPIRATION WITH TVAC (NIPRO) AND DILATION WITH STARLING (BSJ)WERE PERFORMED. STENOSIS DUE TO STENT THROMBOSIS WAS RESOLVED AND THE PROCEDURE WAS COMPLETED. THERE HAS BEEN NO PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75133 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NONE NIU COOK IRELAND LTD C777742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention