BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1941932 · Received December 30, 2010

    Report

    Report Number
    3005099803-2010-05384
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    October 29, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY: (B)(4). (B)(4) - MEDICAL INTERVENTION REQUIRED. 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 WITHIN THE DISTAL COMMON BILE DUCT OF A PATIENT, ON (B)(6) 2010, AS PART OF THE (B)(4). ACCORDING TO THE COMPLAINANT, THE PATIENT WAS DIAGNOSED WITH CHRONIC PANCREATITIS IN 1991. ON (B)(6) 2010 A PRE-STUDY STENT PLACEMENT CHOLANGIOGRAM REVEALED A DISTAL BILIARY STRICTURE. ON (B)(6) 2010 LIVER FUNCTION TESTS WERE PERFORMED AND RECORDED. ON (B)(6) 2010 NO BASELINE BILIARY SYMPTOMS WERE ASSESSED. A SPHINCTEROTOMY WAS PERFORMED PRIOR TO THIS PROCEDURE AND THE STRICTURE HAD BEEN PREVIOUSLY DILATED WITH ONE PLASTIC STENT. THE PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED PRIOR TO STUDY STENT PLACEMENT. A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE. ON (B)(6) 2010, THE 10 MM X 40 MM STENT WAS DEPLOYED IN SATISFACTORY POSITION ACROSS THE STRICTURE. DURING THE STENT PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED RIGHT UPPER QUADRANT PAIN. THE PATIENT WAS TREATED MEDICALLY AS AN INPATIENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT PLACEMENT WAS REPORTED TO BE "POSSIBLE", PER THE INVESTIGATOR. THE INVESTIGATOR'S REPORTED DEVICE CAUSALITY ASSESSMENT WAS REPORTED TO BE "RELATED".

    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 M00570820 13467873

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention