BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 2738681 · Received September 5, 2012

    Report

    Report Number
    3001845648-2012-00049
    Event Type
    Malfunction
    Date Received
    September 5, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 10, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PMA / 510(K) NUMBERS ARE K043481 AND K051124. THERE WERE NO ZIB6-80-12.0-60 DEVICES OF LOT NUMBER C702596 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED WAS NOT AVAILABLE FOR EVAL. IT IS NOT POSSIBLE TO CONFIRM THIS COMPLAINT OR DETERMINE THE ROOT CAUSE AS THE DEVICE WAS NOT RETURNED FOR EVAL OR IMAGES WERE NOT PROVIDED. PRIOR TO DISTRIBUTION ALL ZIB6-80-12.0-60 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR ZIB6-80-12.0-60 OF LOT NUMBER C702596 RELATED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE FRACTURED STENT REMAINS IN THE PT. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND IT IS BELIEVED THAT THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. CUSTOMER QA WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE ZILVER 635 BILIARY SELF-EXPANDING STENT FRACTURED DURING POST DILATION. THE 12 MM DIAMETER BALLOON WAS BEING EXPANDED WITH A SIZE 10MM ANGIOPLASTY BALLOON AND FRACTURED BEFORE THE STENT REACHED NORMAL PRESSURE. INFO RECEIVED ON THE SUBMITTED MEDWATCH REPORT (B)(4) 2012: THE STENT WAS DEPLOYED IN THE PT. THE BALLOON WAS INFLATED TO DILATE THE STENT AND BEFORE THE BALLOON WAS EVEN INFLATED THE STENT FRACTURED. THE STENT SHOULD NOT HAVE FRACTURED. THE PHYSICIAN IMMEDIATELY NOTICED THE FRACTURE AND CLOSELY IMAGED THE STENT. HE DEPLOYED AN ADDITIONAL STENT OVER THE FRACTURE. THIS COULD NOT HAVE BEEN PREVENTED. THIS IS EXTREMELY RARE. IMAGES OF THE EVENT WERE TAKEN AND ARE AVAILABLE. THE FRACTURED STENT REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C702596

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention