BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 1293308 · Received January 22, 2009

    Report

    Report Number
    2134265-2009-00290
    Event Type
    Death
    Date Received
    January 22, 2009
    Report Date
    December 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    SAME CASE AS #2134265-2009-00285, 00286, 00287, 00288, 00291. IT WAS REPORTED THAT POST AN UNSPECIFIED TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. FOUR TAXUS EXPRESS2 ATOM DRUG ELUTING STENTS, SIZES 2.25X12MM, 2.25X24MM AND TWO 2.25X16MM AND A TAXUS LIBERTE' 2.5X16MM DRUG ELUTING STENTS WERE IMPLANTED IN AN UNSPECIFIED VESSEL. AN 8X37X75CM EXPRESS LD OTW WAS PLACED IN AN ILIAC VESSEL. ALL SIX DEVICES WERE IMPLANTED DURING THE SAME PROCEDURE WITH NO COMPLICATIONS. THE PATIENT HAD COMPLAINTS OF BACK PAIN POST PROCEDURE AND A CT SCAN WAS PERFORMED; HOWEVER, NO BLEED WAS FOUND. THE PATIENT WAS DISCHARGED AND DIED ABOUT ONE WEEK LATER. NO ADDITIONAL INFORMATION WAS PROVIDED; HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death