BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2171702 · Received July 22, 2011

    Report

    Report Number
    3005099803-2011-02431
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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

    ACCORDING TO THE COMPLAINANT, A CHOLANGIOGRAM PERFORMED ON (B)(6) 2011 REVEALED A DISTAL BILIARY STRICTURE, WHICH HAD BEEN PREVIOUSLY TREATED WITH A PLASTIC STENT. DURING THE (B)(6) STENT PLACEMENT PROCEDURE, THE PLASTIC STENT WAS REMOVED, AND A SPHINCTEROTOMY WAS NOT PERFORMED. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED FOR A PROXIMAL BILIARY STRICTURE ON (B)(6) 2011. THIS PROCEDURE WAS CONDUCTED AS PART OF THE (B)(4) STUDY. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2011, (B)(6) POST STENT PLACEMENT, THE PATIENT PRESENTED WITH CHOLANGITIS, AS EVIDENCED BY THE SYMPTOMS OF FEVER, CHILLS, NAUSEA, VOMITING, LEFT ABDOMINAL PAIN, EPIGASTRIC PAIN AND DARK URINE. THE PATIENT WAS TREATED WITH AN UNKNOWN MEDICATION. ON (B)(6) 2011, (B)(6) POST STENT PLACEMENT, REINTERVENTION WAS PERFORMED. THE PATIENT UNDERWENT ENDOSCOPIC INTERVENTION FOR SLUDGE REMOVAL SECONDARY TO STENT OCCLUSION. SLUDGE WAS NOTED TO BE PROXIMAL TO THE STUDY STENT. THE STENT REMAINS IMPLANTED. THE EVENT WAS REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS.

    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 M00570830 13469789

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R