BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1150253 · Received September 3, 2008

    Report

    Report Number
    3005099803-2008-04278
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 THAT DURING A BILIARY STENTING TREATMENT PROCEDURE DETACHMENT OCCURRED. THE TARGET STRICTURE WAS AN UNSPECIFIED LOCATION WITHIN THE BILIARY SYSTEM. A 10FR/7CM BILIARY STENT HAD BEEN ADVANCED INTO THE PT TO TREAT THE TARGET STRICTURE. "AS THE BILIARY STENT WAS IN PLACE FOR THE PROCEDURE, THE DISTAL FLAP BROKE-OFF FROM THE DEVICE. THE BROKEN STENT MIGRATED TO THE CHOLEDOCHAL." THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE BY UNSPECIFIED MEANS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00539310 11161077

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R