BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1131035 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-03371
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    June 18, 2004
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    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 BATCH HISTORY, 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

    IT WAS REPORTED FROM THE "RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT OF BILIARY STENTS" THAT FOLLOWING A BILIARY STENTING TREATMENT PROCEDURE, STENT MIGRATION OCCURRED. THE TARGET LESION WAS A BENIGN, DISTAL, COMMON BILE DUCT STRICTURE. A 10X80 COVERED BILIARY WALLSTENT WAS IMPLANTED TO TREAT THE TARGET STRICTURE. NINETY ONE DAYS LATER, MILD STENT MIGRATION WITHIN THE BILIARY DUCT WAS NOTICED, AND THE STENT WAS REMOVED FOR UNSPECIFIED REASONS USING BALLOON "DILARION" AND FORCEPS. THE REMOVAL PROCESS WAS "TECHNICALLY DIFFICULT" DUE TO "STENT FORSHORTENING AND DURATION OF INDWELL". THERE WERE NO CLINICAL COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569720

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other