BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE

    MDR report key: 2023916 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00907
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-SURGICAL MEDICAL INTERVENTION PERFORMED; HOSPITALIZED; ELEVATED LIVER TESTS. (B)(4) - THE REPORTED ISSUE OF STENT BLOCKED/OCCLUDED. 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 WALLSTENT RX BILIARY COVERED ENDOPROSTHESES WAS IMPLANTED WITHIN THE COMMON BILE DUCT OF A CANCER PATIENT, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A NON RESECTABLE MALIGNANT STRICTURE WITHIN THE COMMON BILE DUCT. POST PROCEDURE, ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH JAUNDICE AND ELEVATED LIVER TESTS. AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE REVEALED THAT THE STENT WAS BLOCKED WITH TUMOR OVERGROWTH. THE PHYSICIAN ATTRIBUTED TUMOR PROGRESSION AS WELL AS OTHER UNKNOWN CO MORBIDITIES TO HAVE ALSO CONTRIBUTED TO THE PATIENT'S JAUNDICE. THE PATIENT WAS HOSPITALIZED AND OBSERVED FOR FOUR DAYS, IN WHICH TIME A SECOND STENT WAS PLACED. THE JAUNDICE WAS REPORTED TO BE RESOLVED, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00569710 12643824

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R