BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM

    MDR report key: 2173073 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02437
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 STENT WAS USED TO TREAT A PANCREAS TUMOR. ACCORDING TO THE COMPLAINANT, AFTER DILATING THE STRICTURE WITH A 6MM HURRICANE BALLOON, THE PHYSICIAN ATTEMPTED TO PASS THE STENT DELIVERY SYSTEM THROUGH THE COMMON BILE DUCT STENOSIS. DURING THIS ATTEMPT, THE STENT DELIVERY SYSTEM KINKED AND COULD NOT CROSS THE STRICTURE. THE STENT DELIVERY SYSTEM WAS REMOVED WITH THE STENT STILL FULLY CONSTRAINED. THE PHYSICIAN DILATED THE STRICTURE AGAIN WITH THE 6MM HURRICANE BALLOON AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER WALLFLEX FULLY COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570730 14330164

    Patients

    Seq Age Sex Outcome Treatment
    1