BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 1974908 · Received January 31, 2011

    Report

    Report Number
    3005099803-2011-00211
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4) RELATES TO (B)(4) FOR THE REPORTED ISSUE OF STENT RESTENOSIS. (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED DURING A STENTING PROCEDURE ON (B)(6) 2010. THIS STENT WAS IMPLANTED AS PART OF THE (B)(6) STUDY. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A MID- BILIARY STRICTURE. THIS STRICTURE HAD BEEN PREVIOUSLY TREATED WITH BOTH A SPHINCTEROTOMY AND A PLASTIC STENT. DURING THE (B)(6) 2010 STENTING PROCEDURE, THE PLASTIC STENT WAS NOT REMOVED AND AN ADDITIONAL SPHINCTEROTOMY WAS NOT PERFORMED. THE WALLFLEX STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. THE SUBJECT WAS DISCHARGED (B)(6) 2010. ON (B)(6) 2010, THE PATIENT UNDERWENT A PER-PROTOCOL STENT REMOVAL. ON (B)(6) 2011, THE PATIENT PRESENTED WITH A RECURRENT STRICTURE. THE SUBJECT UNDERWENT RE-INTERVENTION WITH THREE PLASTIC STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK475

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR