BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3492262 · Received November 27, 2013

    Report

    Report Number
    3005099803-2013-14354
    Event Type
    Death
    Date Received
    November 27, 2013
    Date of Event
    November 12, 2013
    Report Date
    November 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT OF STENT MIGRATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED STENT FOUND THAT IT WAS FULLY EXPANDED. THE STENT COVER WAS TORN HORIZONTALLY AND LONGITUDINALLY AT SEVERAL LOCATIONS ALONG ITS LENGTH. IT WAS ALSO NOTED THAT A STENT WIRE AT THE FLARED END WAS PULLED/UNRAVELED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE (DFU). THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE (EXACT DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A STRICTURE DUE TO ESOPHAGEAL CANCER. APPROXIMATELY ONE WEEK AFTER THE STENT WAS IMPLANTED, A LEAKAGE WAS NOTED AND THE STENT WAS REMOVED ON (B)(4) 2013. SOMETIME FOLLOWING STENT REMOVAL, BLEEDING WAS NOTED (EXACT DATE UNKNOWN). IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY, WAS HOSPITALIZED AND DIED ON (B)(4) 2013. IN THE PHYSICIAN¿S ASSESSMENT, THE CAUSE OF DEATH WAS BLEEDING DUE TO ESOPHAGEAL CANCER AND THE STENT ISSUES MAY HAVE LED TO THE PATIENT¿S DEATH. AT THIS TIME, BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. UPDATED INFORMATION: THE STENT WAS IMPLANTED ON (B)(4) 2013. ON (B)(4) 2013, THE STENT WAS REMOVED AND IT WAS NOTED THAT THE STENT MIGRATED ABOUT 3 CM DOWN THE GASTRIC TUBE AND THE STENT COVER WAS BROKEN. FINGER COMPRESSION ON THE AFFECTED SITE, EMERGENT STERNOTOMY, REPLACEMENT OF ASCENDING AORTA, AND RIGHT SUBCLAVIAN ARTERY BYPASS WERE DONE TO ADDRESS THE BLEEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE (EXACT DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A STRICTURE DUE TO ESOPHAGEAL CANCER. APPROXIMATELY ONE WEEK AFTER THE STENT WAS IMPLANTED, A LEAKAGE WAS NOTED AND THE STENT WAS REMOVED ON (B)(6) 2013. SOMETIME FOLLOWING STENT REMOVAL, BLEEDING WAS NOTED (EXACT DATE UNKNOWN). IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY, WAS HOSPITALIZED AND DIED ON (B)(6) 2013. IN THE PHYSICIAN¿S ASSESSMENT, THE CAUSE OF DEATH WAS BLEEDING DUE TO ESOPHAGEAL CANCER AND THE STENT ISSUES MAY HAVE LED TO THE PATIENT¿S DEATH. AT THIS TIME, BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE (EXACT DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A STRICTURE DUE TO ESOPHAGEAL CANCER. APPROXIMATELY ONE WEEK AFTER THE STENT WAS IMPLANTED, A LEAKAGE WAS NOTED AND THE STENT WAS REMOVED ON (B)(6) 2013. SOMETIME FOLLOWING STENT REMOVAL, BLEEDING WAS NOTED (EXACT DATE UNKNOWN). IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY, WAS HOSPITALIZED AND DIED ON (B)(6) 2013. IN THE PHYSICIAN¿S ASSESSMENT, THE CAUSE OF DEATH WAS BLEEDING DUE TO ESOPHAGEAL CANCER AND THE STENT ISSUES MAY HAVE LED TO THE PATIENT¿S DEATH. AT THIS TIME, BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. UPDATED INFORMATION: THE STENT WAS IMPLANTED ON (B)(6) 2013. ON (B)(6) 2013, THE STENT WAS REMOVED AND IT WAS NOTED THAT THE STENT MIGRATED ABOUT 3 CM DOWN THE GASTRIC TUBE AND THE STENT COVER WAS BROKEN. FINGER COMPRESSION ON THE AFFECTED SITE, EMERGENT STERNOTOMY, REPLACEMENT OF ASCENDING AORTA, AND RIGHT SUBCLAVIAN ARTERY BYPASS WERE DONE TO ADDRESS THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618105 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513850 0015738829

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| H| R