BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 3922113 · Received May 30, 2014

    Report

    Report Number
    3001845648-2014-00092
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K) #; K040505, K043481 AND K051124. THE DEVICE INVOLVED IN THIS COMPLAINT IS ZIB6-80-14.0-60 (LOT # C72370). A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED WAS NOT AVAILABLE FOR EVALUATION. IMAGES OF THE EVENT HAVE BEEN RECEIVED AND HAVE BEEN FORWARDED FOR CLINICAL REVIEW. ON RECEIPT OF THE IMAGE REVIEW, ANY RELEVANT ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW UP REPORT. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILVER 635 BILIARY SELF-EXPANDING STENT SYSTEM AND ZILVER STENT WITH GOLD RIVETS (ZIB6-80-14.0-60 LOT # C782370) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PRIOR TO THE DISTRIBUTION ALL ZILVER 635 BILIARY SELF-EXPANDING STENT SYSTEMS ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THE COMPLAINT DESCRIPTION INDICATES THAT THE PHYSICIAN WAS PERFORMING A BALLOON ANGIOPLASTY IN THE SUBCLAVIAN ARTERY. THE DEVICE INVOLVED IN THIS COMPLAINT IS A ZIB6-80-14.0-60 DEVICE. THIS IS A ZILVER BILIARY STET AND THE IFU WHICH ACCOMPANIES THIS DEVICE CONTAINS THE FOLLOWING TEXT: "INTENDED USE - THE ZILVER 518 AND 635 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. THE STENT WAS USED IN THE SUBCLAVIAN ARTERY AND NOT IN THE BILIARY TREE. AS PER THE INFORMATION PROVIDED, THE STENT REMAINS IN THE PATIENT AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS ISSUE . QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    DURING A BALLOON ANGIOPLASTY, A BALLOON WAS PLACED IN THE SUBCLAVIAN STENOSIS AND DILATED. THE PHYSICIAN THEN PLACED A STENT AND WHEN PERFORMING POST BALLOON DILATION, LOOKED AT THE SCREEN AND NOTICED THAT THE STENT LOOKED FRACTURED AND ELONGATED. THE PHYSICIAN ATTEMPTED TO RETRIEVE IT BUT WAS UNSUCCESSFUL. HOWEVER THE PHYSICIAN NOTED SATISFACTION WITH HOW THE STENT WAS PERFORMING AT THE DISTAL END AND FELT THAT THE STENT FRACTURE AND ELONGATION WOULD CAUSE NO HARM TO THE PATIENT AND THE STENT REMAINS IN THE PATIENT. THE STENT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320038 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C782370

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention