BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 2776637 · Received October 3, 2012

    Report

    Report Number
    3001845648-2012-00057
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    P050017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO (B)(4) DEVICES OF LOT NUMBER C780057 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED WAS NOT AVAILABLE FOR EVALUATION. IT IS NOT POSSIBLE TO CONFIRM THIS COMPLAINT AS THE STENT WAS NOT RETURNED FOR EVALUATION AS IT IS STILL IN THE PATIENT AND NO IMAGES WERE PROVIDED. THE COMPLAINT INFORMATION PROVIDED INDICATED ¿COMPLETE TRANSECTION OF THE STENT ¿ A WEEK AND HALF POST PLACEMENT. THE ZILVER STENT WAS PLACED INSIDE A BOSTON SCIENTIFIC WALL STENT. THE REASON THE ZILVER WAS PLACED WAS DUE TO A BALLOON RUPTURE. THE BALLOON MATERIAL WAS FOUND AND ALSO FOUND THE STENT HAD SEPARATED.¿ STENT STRUT FRACTURE IS A KNOWN POTENTIAL ADVERSE EFFECTIVE AS PER INSTRUCTION FOR USE IFU0043-7. IFU0063-7 SECTION ¿POTENTIAL ADVERSE EVENTS¿ ADVISES USER AS FOLLOWS ¿POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: STENT STRUT FRACTURE.¿THE FOLLOWING COMMENTS ARE ALSO INCLUDED IN THE PRECAUTIONS SECTION: OF IFU0043-7 ¿BRANCH TESTING SUGGESTS THAT AN INCREASED POTENTIAL FOR STRUT FRACTURE MAY BE ASSOCIATED WITH OVERLAPPING ZILVER STENTS IN THE PERIPHERAL VASCULATURE.¿ IN THIS CASE THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. IT HAS BEEN CONFIRMED THAT THE PATIENT HAS BEEN DISCHARGED AND IS OK. THE COMPONENT INVOLVED IN THIS COMPLAINT IS RMN# (B)(4) (STENT WITH GOLD RIVETS) OF LOT# CH769689. A REVIEW OF THE MANUFACTURING RECORD FOR LOT# CH769689 DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL (B)(4) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR (B)(4) OF LOT NUMBER C780057 REVEALED NO DISCREPANCIES RELATED TO THIS COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND IT IS BELIEVED THAT THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    COMPLETE TRANSECTION OF THE STENT ¿ A WEEK AND HALF POST PLACEMENT. THE ZILVER STENT WAS PLACED INSIDE A BOSTON SCIENTIFIC WALL STENT. THE REASON THE ZILVER WAS PLACED WAS DUE TO THE BALLOON RUPTURE. THE BALLOON MATERIAL WAS FOUND AND ALSO FOUND THE STENT HAD SEPARATED. THE PATIENT HAS BEEN DISCHARGED AND OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER 635 VASCULAR SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C780057

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK