BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT¿ RX BILIARY

    MDR report key: 2485556 · Received March 9, 2012

    Report

    Report Number
    3005099803-2012-00862
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER 18 YEARS OLD. (B)(4) FOR THE REPORTED ISSUE OF STENT POSITIONING/PLACEMENT PROBLEM. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN 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 WALLSTENT RX BILIARY ENDOPROSTHESES WAS IMPLANTED WITHIN A STRICTURE IN THE COMMON BILE DUCT ON (B)(6) 2012, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND HAD NOT BEEN DILATED PRIOR TO THE STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED SOME DIFFICULTY IN DEPLOYING THE STENT DUE TO KINKING IN THE DELIVERY CATHETER. SUBSEQUENTLY, WITH THE AID OF FLUOROSCOPIC GUIDANCE, THE STENT DEPLOYED; HOWEVER, IT WAS INADVERTENTLY PLACED TOO PROXIMAL IN THE COMMON BILE DUCT AND EXITED AT THE PAPILLA. REPORTEDLY, THE PHYSICIAN HAD DIFFICULTIES IN CONTROLLING THE POSITION OF THE STENT; HOWEVER, IT WAS NOTED THAT THE STENT WAS COVERING THE STENOSIS. THE PHYSICIAN IS CONCERNED THAT THE STENT MAY MIGRATE FROM THE COMMON BILE DUCT, BUT HE DOES NOT PLAN TO REPOSITION THE STENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT¿ RX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00569640 0014721653

    Patients

    Seq Age Sex Outcome Treatment
    1