BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY STENT W/UNISTEP PLUS

    MDR report key: 1181717 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04949
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K982005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, A STENT LENGTH DISCREPANCY WAS NOTED. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). A 10X60 BLRY ENDO UNI PLUS HALO7.5F/219CM STENT WAS IMPLANTED TO TREAT THE TARGET LESION. FOLLOWING DEPLOYMENT, THE STENT APPEARED TO MEASURE 8CM UNDER FLUOROSCOPY INSTEAD OF 6CM. THE PHYSICIAN FELT THERE WAS "TOO MUCH STENT HANGING IN THE DUODENUM." THERE WERE NO PATIENT COMPLICATIONS REPORTED; HOWEVER, THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY STENT W/UNISTEP PLUS FGE BOSTON SCIENTIFIC H965430500 11808211

    Patients

    Seq Age Sex Outcome Treatment
    1