BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1040644 · Received May 8, 2008

    Report

    Report Number
    3005099803-2008-00431
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED, BUT AN EVAL IS NOT COMPLETE; THE REPORTED INCORRECT STENT SIZE HAS NOT BEEN CONFIRMED. A SEARCH OF THE COMPLAINT DATABASE REVEALED ONE OTHER COMPLAINT REPORTED FOR THIS LOT, FOR AN UNRELATED FAILURE MODE (STENT WIRES PROTRUDING THE OUTER SHEATH). THE MARCH 2008 15-MONTH RX BILIARY STENT PROCEDURE FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THE PROCEDURE DATE IS UNK. A WALLSTENT RX BILIARY ENDOPROSTHESIS WAS USED DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE PROSTHESIS EXCEEDED THE SIZE SPECS, AND BLOCKED OFF THE BILIARY DUCT. AFTER WITHDRAWAL, THE PROSTHESIS WAS MEASURED AND FOUND TO BE 11CM IN LENGTH INSTEAD OF 10 CM. A PROSTHESIS OF 8 CM (MANUFACTURER UNK) WAS SUCCESSFULLY IMPLANTED." NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC IRELAND, LTD M00569810 9674789

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK