BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 SELF-EXPANDING STENT

    MDR report key: 2814384 · Received October 26, 2012

    Report

    Report Number
    3001845648-2012-00063
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K033348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) NUMBERS ARE K042518 AMD K050698. THERE WERE NO ZIB5-125-5.0-80 DEVICES OF LOT NUMBER C723384 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE RELATED TO THIS COMPLAINT WAS NOT RETURNED FOR EVAL AND IMAGES WERE NOT PROVIDED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE COMPLAINT INFO PROVIDED INDICATED THAT THE PHYSICIAN WAS DEPLOYING THE STENT. THE DISTAL PORTION DEPLOYED FINE, HOWEVER THE MIDDLE SECTION LOOKED AS THOUGH THE STENT WAS UNRAVELLED. THE PROXIMAL PORTION DEPLOYED FINE. THIS RESULTED IN THE EMBOLIZING OF THE PT'S ARTERY AND THE PT REQUIRING SURGERY. THE COMPONENT INVOLVED IN THS COMPLAINT RMN# (B)(4) (STENT WITH GOLD RIVETS). RMN# (B)(4) (STENT WITH GOLD RIVETS) OF LOT# CH717563 WERE USED IN THE MFR OF (B)(4) DEVICES OF LOT NUMBER C723384. A REVIEW OF THE MFG RECORDS FOR LOT # CH717563 DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. A HEALTH RISK ASSESSMENT WAS INITIATED TO FURTHER INVESTIGATE STENT FRACTURES DURING DEPLOYMENT. PRIOR TO DISTRIBUTION ALL ZIB5-125-5.0-80 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR ZIB5-125-5.0-80 DEVICES OF LOT NUMBER C723384 REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. THE PT IS CURRENTLY IN A STABLE CONDITION. THE 2 YR 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

    THE PHYSICIAN WAS DEPLOYING THE 518 STENT. THE DISTAL PORTION DEPLOYED FINE, HOWEVER THE MIDDLE SECTION LOOKED AS THOUGH THE STENT WAS UNRAVELLED. THE PROXIMAL PORTION DEPLOYED FINE. THIS RESULTED IN THE EMBOLIZING OF THE PTS ARTERY AND HAVING TO SEND THE PT TO SURGERY. PER SALES REP, THE PT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER 518 SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C723384

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention