BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 2086870 · Received April 14, 2011

    Report

    Report Number
    3001845648-2011-00015
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 21, 2011
    Manufacturer
    COOK IRELAND LTD.
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PMA / 510(K) NUMBERS ARE K043481 AND K051124. THE LOT NUMBER OF THE ZIB6-80-12.0-60 DEVICE INVOLVED IN THIS COMPLAINT IS UNKNOWN; THEREFORE, WE CANNOT DETERMINE IF A DEVICE OF THE SAME LOT NUMBER IS IN STOCK. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED WAS NOT AVAILABLE FOR EVALUATION. THE COMPLAINT DESCRIPTION CONTAINED THE FOLLOWING INFORMATION: "STENT WAS PLACED APPROXIMATELY SEVEN DAYS PRIOR TO DIALYSIS CATHETER PROCEDURE IN BRACHIOCEPHALIC VEIN, PERHAPS SLIGHTLY INTO THE SVC. DURING DIALYSIS CATHETER PROCEDURE, A 14 OR 16 FR SHEATH WITH J WIRE MUST HAVE SNAGGED THE STENT AND THE STENT BROKE IN HALF, SENDING HALF OF THE STENT INTO THE PATIENT'S RIGHT VENTRICLE ..." THE DEVICE INVOLVED IN THIS COMPLAINT IS A ZIB6-80-12.0-60 DEVICE. THIS IS A ZILVER BILIARY STENT AND THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE, CONTAINS THE FOLLOWING: "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 INFORMATION PROVIDED. PRIOR TO DISTRIBUTION, ALL ZIB6-80-12.0-60 DEVICES AR SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF MANUFACTURING RECORDS CANNOT BE CONDUCTED AS THE DEVICE LOT NUMBER IS UNKNOWN. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME, AS BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT APPEARS TO BE DUE TO USER ERROR. 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

    STENT WAS PLACED IN BRACHIOCEPHALIC VEIN, PERHAPS SLIGHTLY INTO THE SUPERIOR VENA CAVA, APPROXIMATELY SEVEN DAYS PRIOR TO DIALYSIS CATHETER PROCEDURE. DURING DIALYSIS CATHETER PROCEDURE, THE STENT BROKE IN HALF, SENDING HALF OF THE STENT INTO THE PATIENT'S RIGHT VENTRICLE. THE PATIENT HAD ARRHYTHMIA. THE PHYSICIAN DECIDED TO SEND THE PATIENT TO HAVE THE STENT REMOVED. OPEN SURGERY WAS PERFORMED ON THE PATIENT TO REMOVE THE STENT. THE MOST RECENT REPORT INDICATES THE PATIENT IS DOING OKAY.

    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. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R