BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057

    MDR report key: 1946332 · Received January 4, 2011

    Report

    Report Number
    3005099803-2010-05413
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):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)(4) WALLFLEX FULLY COVERED (B)(4) STUDY. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A PROXIMAL 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 REMOVED AND AN ADDITIONAL SPHINCTEROTOMY WAS NOT PERFORMED. THE WALLFLEX STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. THE SUBJECT WAS TREATED AS AN OUTPATIENT. ON (B)(6), 2010, THE SUBJECT UNDERWENT A PER-PROTOCOL STENT REMOVAL. DURING THIS PROCEDURE, THE COMPLAINANT NOTED THAT THE STENT HAD MIGRATED JUST PROXIMAL OF THE PAPILLA. ALTHOUGH THIS MIGRATION MADE IT MORE DIFFICULT TO REMOVE THE STENT, THE PHYSICIAN WAS ABLE TO REMOVE IT WITHOUT ANY COMPLICATIONS OR ADVERSE EVENTS. THE COMPLAINANT NOTED THAT THERE WERE NO ISSUES WITH THE STENT'S PROFILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057 CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570840 13051894

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR