BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1052545 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00520
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    February 29, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR-REPORTABLE SCENARIO; HOWEVER, EVALUATION OF THE RETURNED DEVICE, WHICH WAS COMPLETED ON APRIL 24, 2008, REVEALED AN MDR-REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS SUBMITTED BASED ON THE EVALUATION RESULTS. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT SEVERAL STENTS WIRES HAD PERFORATED THE OUTER SHEATH (SEE FIGURE 1, PAGE 3). THE CAUSE OF THE DAMAGE IS UNKNOWN. THE DEVICE HISTORY RECORD (DHR) FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED TWO ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT (FOR THE SAME FAILURE MODE). THE APRIL 2008 15-MONTH RX BILIARY STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A WALLSTENT RX BILIARY ENDOPROSTHESIS WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE IN AN ADULT FEMALE PATIENT (AGE AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, THE OUTER SHEATH COULD NOT BE RETRACTED (AS INTENDED) TO DEPLOY THE STENT. THE PHYSICIAN USED A SECOND WALLSTENT RX BILIARY ENDOPROSTHESIS TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS REPORTED AS "GOOD" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC IRELAND, LTD. M00569710 11365293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK