BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 2142094 · Received May 25, 2011

    Report

    Report Number
    3001845648-2011-00020
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 28, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 C614229 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. 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 ZIB6-12.0-60 OF LOT NUMBER C614229 REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS THIS IS BELIEVED TO BE AN ISOLATED INCIDENT. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND IT IS BELIEVED THAT THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE.

    Description of Event or Problem · 1

    AFTER INSERTION OF THE DIALYSIS CATHETER AND DURING RECOVERY, THE PT STARTED HAVING ARRHYTHMIA. USING A TRANS-ESOPHAGEAL ECHO, THE PRACTIONER FOUND THAT THE WIRE WENT THROUGH THE STRUT AND THE STENT HAD SHEARD OFF. THIS STENT WAS PLACED THREE DAYS EARLIER DURING A FISTULOGRAM. THE PT WAS TRANSFERRED TO A LARGER FACILITY AND UNDERWENT SURGERY TO REMOVE THE STENT. THE PT CAME OUT OF SURGERY WITH NO ADVERSE EFFECTS.

    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 C614229

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention