BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING VASCULAR STENT

    MDR report key: 2572400 · Received May 8, 2012

    Report

    Report Number
    3001845648-2012-00022
    Event Type
    Injury
    Date Received
    May 8, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PMA / 510(K) NUMBER FOR THIS PRODUCT IS POSSIBLY P050017/S002 AND 003, HOWEVER, AS THE ACTUAL RPN IS UNKNOWN, THIS CANNOT BE CONFIRMED. THE ACTUAL PART NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THE PART NUMBER OR LOT NUMBER WERE NOT PROVIDED; THEREFORE, IT IS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED TO COOK IRELAND FOR EVALUATION, THEREFORE, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. IMAGES WERE PROVIDED IN RELATION TO THIS COMPLAINT. BASED ON THE IMAGES PROVIDED, IT DOES APPEAR THAT A RIVET MAY HAVE DISLODGED, BUT IT CANNOT BE CONFIRMED IF ONE IS MISSING FROM THE STENT. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. PRIOR TO DISTRIBUTION, ALL ZILVER 635 SELF-EXPANDING VASCULAR STENTS ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZILVER 635 DEVICE INVOLVED IN THIS COMPLAINT REPORT COULD NOT BE REVIEWED AS THE SPECIFIC PART NUMBER AND LOT NUMBER OF THE COMPLAINT DEVICE WERE UNKNOWN. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS PRODUCT FAMILY. THIS COMPLAINT THEREFORE REPRESENTS AN ISOLATED OCCURRENCE. HOWEVER, COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    DURING ADVANCEMENT OF THE ANSEL INTRODUCER, A MARKER FROM THE PREVIOUS PLACED ZILVER STENT, A GOLD MARKER, APPEARED TO DISLODGE AND FLOAT AND STOP. THE MARKER REMAINS IN THE PT. DISTRICT MANAGER CONFIRMED THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER 635 SELF-EXPANDING VASCULAR STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK