BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING STENT

    MDR report key: 2459865 · Received February 13, 2012

    Report

    Report Number
    3001845648-2012-00007
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBERS FOR THIS PRODUCT ARE: K043481 AND K051124. THERE WERE NO ZIB6-80-14.0-60 DEVICES OF LOT NUMBER OF C707300 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED WAS NOT RETURNED FOR EVAL. THE COMPLAINT DESCRIPTION CONTAINED THE FOLLOWING INFO: "THE PHYSICIAN DEPLOYED THE STENT IN THE RIGHT NOMINAL VEIN, POST DILATED WITH 14MM BALLOON. ON SECOND INFLATION, THE VESSEL OPENED AND THE STENT MIGRATED TO THE RIGHT ATRIUM. THE PT WAS TAKEN TO THE HOSPITAL WHERE THE INTERVENTIONAL RADIOLOGY TEAM ATTEMPTED TO RETRIEVE THE STENT AND WAS UNSUCCESSFUL. THE INITIAL PHYSICIAN CALLED IN A CARDIAC SURGEON TO REMOVE THE DEVICE VIA AN OPEN PROCEDURE." THE DEVICE INVOLVED IN THIS COMPLAINT IS A ZIB6-80-14.0-60 DEVICE. THIS IS A ZILVER BILIARY STENT AND THE INSTRUCTIONS FOR USE (IFU) WHICH ACCOMPANIES THIS DEVICE, IFU0042-4, CONTAINS THE FOLLOWING TEXT: "INTENDED USE- THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE. WARNINGS- THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN THE VASCULAR SYSTEM HAVE NOT BEEN ESTABLISHED." THIS EVENT CAN BE DESCRIBED AS OFF LABEL USE BASED ON THE INFO PROVIDED AS THIS STENT IS INDICATED FOR ARTERIAL USE, NOT THE VENOUS SYSTEM. THE PHYSICIAN USED THE STENT IN AN OFF-LABEL MANNER. PRIOR TO DISTRIBUTION ALL ZIB6-80-14.0-60 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF MANUFACTURING RECORDS FOR ZIB6-80-14.0-60 OF LOT NUMBER C707300 REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS THIS IS CONSIDERED 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

    THE PHYSICIAN DEPLOYED THE STENT IN THE RIGHT NOMINAL VEIN, POST DILATED WITH 14MM BALLOON. ON SECOND INFLATION, THE VESSEL OPENED AND THE STENT MIGRATED TO THE RIGHT ATRIUM. THE PT WAS TAKEN TO THE HOSPITAL WHERE THE INTERVENTIONAL RADIOLOGY TEAM ATTEMPTED TO RETRIEVE THE STENT BUT WERE UNSUCCESSFUL. THE INITIAL PHYSICIAN CALLED IN A CARDIAC SURGEON TO REMOVE THE DEVICE VIA AN OPEN PROCEDURE.

    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 C707300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening