BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ BILIARY RX STENT SYSTEM

    MDR report key: 5166845 · Received October 21, 2015

    Report

    Report Number
    3005099803-2015-03001
    Event Type
    Injury
    Date Received
    October 21, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 29, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K140630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PANCREATITIS. ENTEROCOCCUS FAECALIS BACTEREMIA. (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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS IMPLANTED TO TREAT A 1.8CM MALIGNANT TUMOR AT THE HEAD OF THE PANCREAS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE E7034 WALLFLEX BILIARY PREOPERATIVE DRAINAGE NATX CLINICAL TRIAL. THE PATIENT DID NOT UNDERGO A CHOLECYSTECTOMY. BASELINE ASSESSMENT OF BILIARY OBSTRUCTIVE SYMPTOMS (ABOS) WAS CONDUCTED WITH NO REPORTED SYMPTOMS. THE PATIENT'S KARNOFSKY SCORE WAS REPORTED AS 100. TISSUE DIAGNOSIS WAS OBTAINED USING EUS-FNA. BASELINE LABORATORY TESTS WERE CONDUCTED ON (B)(6) 2015. CHEMOTHERAPY AND RADIATION ARE PLANNED FOR THIS PATIENT. ACCORDING TO THE COMPLAINANT, THE PATIENT DID NOT REQUIRE A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) FOR STENT PLACEMENT. INITIAL STENT PLACEMENT WAS PERFORMED ON (B)(6) 2015 AND WAS COMPLETED AS AN OUTPATIENT PROCEDURE. A WALLFLEX BILIARY RX FULLY COVERED STENT STUDY STENT WAS IMPLANTED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. A PRIOR BILIARY SPHINCTEROTOMY HAD NOT BEEN PERFORMED. A PRIOR PANCREATIC SPHINCTEROTOMY HAD NOT BEEN PERFORMED. A BILIARY AND PANCREATIC SPHINCTEROTOMY WERE NOT PERFORMED DURING THIS PROCEDURE. A PROPHYLACTIC PANCREATIC STENT WAS NOT PLACED. THE PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. ON (B)(6) 2015, THE PATIENT PRESENTED WITH ACUTE PANCREATITIS, POST PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 AND DISCHARGED ON (B)(6) 2015 AS THE ACUTE PANCREATITIS HAD RESOLVED. THE PATIENT HAD PRESENTED WITH ENTEROCOCCUS FAECALIS BACTEREMIA ON (B)(6) 2015. THE PATIENT REQUIRED MEDICATION AND PROLONGED INPATIENT GENERAL HOSPITALIZATION. THE EVENT OF ENTEROCOCCUS FAECALIS BACTEREMIA WAS REPORTEDLY NOT RELATED TO THE WALLFLEX BILIARY RX FULLY COVERED STENT BUT WAS DEEMED RELATED TO THE WALLFLEX BILIARY RX FULLY COVERED STENT PLACEMENT PROCEDURE. THE EVENT HAS NOT YET RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693892 WALLFLEX¿ BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570520 17800754

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention