BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1153343 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04367
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 28, 2003
    Report Date
    August 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS. IT WAS REPORTED THAT APPROX 499 DAYS POST AN RX WALLSTENT PERMALUME 10MMX40MM STENT PLACEMENT IN THE COMMON BILE DUCT (CBD), THE PT EXPERIENCED UNSPECIFIED SYMPTOMS SUGGESTIVE OF OBSTRUCTION. THE PT UNDERWENT A STENT REMOVAL PROCEDURE AT WHICH TIME; THE PHYSICIAN ATTEMPTED TO REMOVED THE DEVICE WITH A "SNARE AND RAT TOOTH FORCEPS", BUT WAS UNABLE TO REMOVE THE DEVICE DUE TO "OVERGROWTH" AT THE PROXIMAL END. THE PHYSICIAN ALSO NOTED "TECHNICAL DIFFICULTIES DURING REMOVAL DUE TO "MAJOR TUMOR BURDEN IMPACTING ACCESS TO THE STENT". AN UNSPECIFIED PLASTIC STENT WAS IMPLANTED THROUGH THE 10MMX40MM RX WALLSTENT PERMALUME. THE FOLLOWING DAY, THE UNSPECIFIED PLASTIC STENT WAS REMOVED AND THE PHYSICIAN IMPLANTED A 10X80 COVERED WALLSTENT IN THE COMMON HEPATIC DUCT. THE PT'S CONDITION RESOLVED WITH PLASTIC STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569700

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R