BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY

    MDR report key: 2153368 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02028
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K982184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED, THE GUIDEWIRE WAS INSERTED THROUGH THE TIP AND OUT THROUGH THE GUIDEWIRE ACCESS PORT. THE STENT WAS ABLE TO BE PARTIALLY DEPLOYED AND RE-CONSTRAINED. THERE WAS SOME RESISTANCE DURING THE RE-CONSTRAINMENT PROCESS BUT THEN FULL DEPLOYMENT OF THE STENT OCCURRED WITHOUT ISSUE. THE SHAFT WAS DISSECTED AND NO ANOMALIES WERE NOTED. THE CAUSE OF THE DEPLOYMENT ISSUE IS ATTRIBUTED TO OPERATIONAL CONTEXT. THE (B)(6) 2008 15-MONTH WALLFLEX BILIARY STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. A LOT HISTORY SEARCH REVEALED NO SIMILAR COMPLAINTS FOR THE REPORTED LOT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A WALLSTENT BILIARY STENT WAS PLACED ON THE SAME DAY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT ONLY EXPANDED AT THE DISTAL END AND THE PHYSICIAN WAS UNABLE TO RELEASE THE STENT FULLY. THE STENT WAS REMOVED AND WAS THEN ABLE TO FULLY EXPAND. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY FGE BOSTON SCIENTIFIC CORPORATION M00569660 11025393

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK