BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1021120 · Received March 27, 2008

    Report

    Report Number
    3005099803-2008-00308
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    FGE
    PMA / PMN Number
    K896163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO SUPPLIED BY THE COMPLAINANT, THE IMPLANT DATE IS APPROXIMATED TO BE IN 2008. THE SUSPECT DEVICE WAS NOT RETURNED FOR EVAL; THEREFORE, THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE IS UNDETERMINED. THE DEVICE HISTORY RECORD (DHR) FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADD'L COMPLAINTS RECORDED FOR THIS LOT.

    Description of Event or Problem · 1

    A WALLSTENT BILIARY ENDOPROSTHESIS WAS USED DURING A STENT IMPLANT PROCEDURE IN THE BILE DUCT OF AN ADULT PT (AGE, GENDER AND WEIGHT UNK). ALTHOUGH THE ACTUAL DATE OF THE IMPLANT PROCEDURE IS UNK, IT TOOK PLACE APPROX TWO WEEKS PRIOR TO THE EVENT DATE (IMPLANT DATE IS APPROXIMATED TO BE IN 2008). ACCORDING TO THE COMPLAINANT, AT A ROUTINE TWO WEEK FOLLOW UP APPOINTMENT, THE PHYSICIAN OBSERVED THAT: "(T)HE STENT (WAS) BLOCKED (BY) TUMOR INGROWTH." THE PHYSICIAN, REPORTEDLY, PLACED A SECOND STENT (MFR UNK) THROUGH THE WALLSTENT BILIARY DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC IRELAND, LTD H965431100 0009508123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention