BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT® ENDOPROSTHESIS

    MDR report key: 3836173 · Received May 28, 2014

    Report

    Report Number
    2134265-2014-02853
    Event Type
    Death
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT MIGRATION AND PATIENT DEATH OCCURRED. THE LESION WAS LOCATED IN A STRICTURE OF THE PRECAVA. THE LESION WAS NOT TORTUOUS, HAD NO BEND, AND MEASURED 30MM IN LENGTH WITH A 20MM VESSEL DIAMETER. A 24X45MM WALLSTENT ENDOPROSTHESIS WAS SELECTED TO TREAT THE LESION. DURING THE PROCEDURE, THE STENT MIGRATED WITHOUT DEPLOYMENT INTO THE RIGHT ATRIUM. THE PHYSICIAN ELECTED TO REMOVE THE STENT FROM THE RIGHT ATRIUM SURGICALLY. DURING THE SURGERY, THE PATIENT EXPIRED AND THE STENT WAS NOT RETRIEVED. THE CAUSE OF DEATH WAS REPORTED TO BE A PULMONARY EMBOLISM. THE PHYSICIAN STATED THE DEATH WAS NOT RELATED TO THE SURGERY AND THAT THE STENT MIGRATION MAY HAVE CAUSED EMBOLIC MATERIAL TO DISLODGE AND CAUSE THE PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313306 WALLSTENT® ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965405110 16017027

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death