BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT? BILIARY

    MDR report key: 3242717 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-06711
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K000308
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.(B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE IS STILL IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT. THIS IS DEFINED AS A COMPLAINT THAT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, THE WALLSTENT BILIARY STENT WAS IMPLANTED ON (B)(6) 2013, DUE TO A STRICTURE OF THE COMMON BILE DUCT (CBD) CAUSING OBSTRUCTIVE JAUNDICE. 48 HOURS POST PROCEDURE, THE PATIENT PRESENTED WITH FEVER AND PAIN, THE STENT HAD NOT FULLY EXPANDED BUT THE STENT WAS PARTIALLY OPENED AND BILE WAS FLOWING OUT. ONE WEEK AFTER THE PROCEDURE THE FEVER AND PAIN HAD RESOLVED AND THE STENT WAS NOTED TO BE FULLY OPENED. THREE WEEKS POST PROCEDURE THE PATIENT HAD NOT RETURNED FOR FOLLOW UP AND THE PHYSICIAN BELIEVED THERE WAS NO FURTHER OBSTRUCTION FOR THE PATIENT. THERE IS NO PLAN TO PLACE ANOTHER STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS IMPLANTED WITHIN THE COMMON BILE DUCT (CBD) ON (B)(6), 2013, DURING A BILIARY STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD PREVIOUSLY HAD AN UNKNOWN PLASTIC STENT PLACED IN THE CBD. THE INDICATION FOR METAL STENT PLACEMENT WAS DUE TO OBSTRUCTIVE JAUNDICE. REPORTEDLY, THE 2 CM LESION WAS LOCATED IN THE MI CBD AND THE PATIENT ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PLASTIC STENT WAS REMOVED AND THE DUCT WAS DILATED USING A BILIARY DILATION BALLOON. THE STENT WAS PLACED WITHOUT ANY ISSUES. TWO DAYS POST PROCEDURE ON (B)(6), 2013, THE PATIENT HAD FEVER AND ABDOMINAL PAIN. A X-RAY WAS TAKEN AND THE PHYSICIAN NOTED THAT THE STENT HAD NOT FULLY EXPANDED. THE PATIENT WAS GIVEN ANTIBIOTICS TO TREAT THE FEVER. THE PHYSICIAN HAS NOT PLANNED TO REMOVE THE STENT, INSTEAD AFTER A WEEK HE WILL TAKE ANOTHER X-RAY TO CONFIRM THE LUMINAL PATENCY OF THE STENT. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342389 WALLSTENT? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965431100

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention