BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT? BILIARY

    MDR report key: 3071464 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-02872
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; WHICH CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. STENT MIGRATION IS IDENTIFIED IN THE DIRECTIONS FOR USE AS AN ANTICIPATED COMPLICATION OF THE USE OF THE DEVICE. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATION, WHICH INDICATES A COMPLAINT WHERE A DEVICE RELATED ROOT CAUSE DOES NOT APPLY AND THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-02872, AND 3005099803-2013-02873 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLSTENT DEVICES WERE USED DURING A BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS CHOLANGIOCARCINOMA. DURING THE PROCEDURE BOTH WALLSTENT BILIARY STENTS WERE PLACED WITHIN THE PATIENT. A FEW MINUTES AFTER THE PROCEDURE BOTH STENTS MIGRATED OUT OF THE COMMON BILE DUCT. BOTH WALLFLEX BILIARY STENTS WERE REMOVED AND PLASTIC STENTS WERE IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE STENT EXCHANGE PROCEDURE WAS REPORTED TO BE STABLE. DESPITE ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-02872, AND 3005099803-2013-02873 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLSTENT DEVICES WERE USED DURING A BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS CHOLANGIOCARCINOMA. DURING THE PROCEDURE BOTH WALLSTENT BILIARY STENTS WERE PLACED WITHIN THE PATIENT. A FEW MINUTES AFTER THE PROCEDURE BOTH STENTS MIGRATED OUT OF THE COMMON BILE DUCT. BOTH WALLFLEX BILIARY STENTS WERE REMOVED AND PLASTIC STENTS WERE IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE STENT EXCHANGE PROCEDURE WAS REPORTED TO BE STABLE. DESPITE ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SINCE (B)(6) 2013, THE FOLLOWING INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC. REPORTEDLY, THE SECOND STENT WAS PLACED BECAUSE THE FIRST STENT MOVED. THE ENDOSCOPE WAS USED TO VISUALIZE THE STENT PLACEMENT 5 MINUTES AFTER IMPLANTATION, DURING THIS VISUALIZATION IT WAS DETERMINED THAT BOTH STENTS HAD MOVED OUT OF THE COMMON BILE DUCT AT THE END OF THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE MALIGNANT STRICTURE WAS 4CM IN LENGTH, THE ANATOMY WAS NOT TORTUOUS AND THE LESION WAS NOT DILATED PRIOR TO STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172646 WALLSTENT? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965430500 15690412

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention