BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM

    MDR report key: 2143186 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02295
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND 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 PARTIALLY COVERED STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE DISTAL COMMON BILE DUCT DUE TO A MALIGNANCY. THE STRICTURE WAS APPROXIMATELY 2CM IN LENGTH. THE STENT WAS PLACED SUCCESSFULLY ON (B)(6), 2010 WITH NO COMPLICATIONS. ON (B)(6), 2011, THE PATIENT DEVELOPED JAUNDICE AND CHOLANGITIS. THE PATIENT HAD A BILIRUBIN LEVEL OF "386" AND A C-REACTIVE PROTEIN (CRP) LEVEL OF "36." THE STENT WAS FOUND TO BE OBSTRUCTED LIKELY DUE TO TUMOR INGROWTH. THE PATIENT UNDERWENT A SECOND ERCP PROCEDURE. DURING THIS PROCEDURE, A SECOND STENT WAS IMPLANTED WITHIN THE EXISTING WALLFLEX STENT. FOLLOWING THE PLACEMENT OF THE SECOND STENT, THE PATIENT'S SYMPTOMS RESOLVED AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    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 M00570740 0012233610

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention