BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX¿ ESOPHAGEAL

    MDR report key: 2890415 · Received December 30, 2012

    Report

    Report Number
    3005099803-2012-06105
    Event Type
    Death
    Date Received
    December 30, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF STENT MIGRATION. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED WITHIN THE ESOPHAGUS OF A PATIENT ON (B)(6) 2012 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A STRICTURE, WITH AN ASSOCIATED POST-SURGICAL TRACHEOESOPHAGEAL FISTULA, WITHIN THE ESOPHAGUS DUE TO ESOPHAGEAL CANCER. THE TERMINALLY ILL PATIENT'S HEALTH WAS REPORTED AS VERY FRAGILE PRIOR TO THE PROCEDURE, WITH SEVERE ESOPHAGEAL CANCER AND TORTUOUS ANATOMY. FURTHERMORE, THE PATIENT WAS UNDERGOING RADIOTHERAPY AND CHEMOTHERAPY PRIOR TO THIS EVENT. THE LESION WAS LOCATED APPROXIMATELY 14 CM DISTAL TO THE START OF THE ESOPHAGUS. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO THE STENT PLACEMENT WITH AN ESOPHAGEAL C.R.E. BALLOON. DURING THE PROCEDURE, A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS SUCCESSFULLY IMPLANTED WITHIN THE ESOPHAGUS OVER A BSC JAGWIRE GUIDEWIRE. NO ISSUES WERE REPORTED DURING THE STENT PLACEMENT; THE PATIENT WAS SAID TO BE "SAFE AND STABLE." APPROXIMATELY THIRTY MINUTES POST PROCEDURE, THE PHYSICIAN EXTUBATED THE PATIENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED DIFFICULTIES BREATHING AND IT WAS CONFIRMED THAT THE STENT HAD MIGRATED THROUGH THE FISTULA INTO THE BRONCHIAL TREE. THE PATIENT UNDERWENT AN EMERGENCY STENT REMOVAL DUE TO THE MIGRATED STENT. THE STENT WAS SUCCESSFULLY REMOVED AND NO FURTHER TREATMENTS WERE PROVIDED. ON (B)(6) 2012, IT WAS CONFIRMED THAT THE PATIENT HAD DEVELOPED A PNEUMOTHORAX, AND SUBSEQUENTLY EXPIRED LATER THAT DAY. THE PATIENT'S DEATH WAS REPORTED AS POSSIBLY DUE TO THE MIGRATION OF THE STENT THROUGH THE FISTULA INTO THE BRONCHIAL TREE, LEADING TO A PNEUMOTHORAX. AN AUTOPSY WAS NOT PERFORMED. PER THE PHYSICIAN, THE GUIDEWIRE AND C.R.E. DILATATION BALLOON USED DURING THE PROCEDURE WORKED AS EXPECTED AND NO ISSUES WERE ENCOUNTERED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED WITHIN THE ESOPHAGUS OF A PATIENT ON (B)(6) 2012 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A STRICTURE, WITH AN ASSOCIATED POST-SURGICAL TRACHEOESOPHAGEAL FISTULA, WITHIN THE ESOPHAGUS DUE TO ESOPHAGEAL CANCER. THE TERMINALLY ILL PATIENT'S HEALTH WAS REPORTED AS VERY FRAGILE PRIOR TO THE PROCEDURE, WITH SEVERE ESOPHAGEAL CANCER AND TORTUOUS ANATOMY. FURTHERMORE, THE PATIENT WAS UNDERGOING RADIOTHERAPY AND CHEMOTHERAPY PRIOR TO THIS EVENT. THE LESION WAS LOCATED APPROXIMATELY 14 CM DISTAL TO THE START OF THE ESOPHAGUS. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO THE STENT PLACEMENT WITH AN ESOPHAGEAL C.R.E. BALLOON. DURING THE PROCEDURE, A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS SUCCESSFULLY IMPLANTED WITHIN THE ESOPHAGUS OVER A BSC JAGWIRE GUIDEWIRE. NO ISSUES WERE REPORTED DURING THE STENT PLACEMENT; THE PATIENT WAS SAID TO BE "SAFE AND STABLE." APPROXIMATELY THIRTY MINUTES POST PROCEDURE, THE PHYSICIAN EXTUBATED THE PATIENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED DIFFICULTIES BREATHING AND IT WAS CONFIRMED THAT THE STENT HAD MIGRATED THROUGH THE FISTULA INTO THE BRONCHIAL TREE. THE PATIENT UNDERWENT AN EMERGENCY STENT REMOVAL DUE TO THE MIGRATED STENT. THE STENT WAS SUCCESSFULLY REMOVED AND NO FURTHER TREATMENTS WERE PROVIDED. ON (B)(6) 2012, IT WAS CONFIRMED THAT THE PATIENT HAD DEVELOPED A PNEUMOTHORAX, AND SUBSEQUENTLY EXPIRED LATER THAT DAY. THE PATIENT'S DEATH WAS REPORTED AS POSSIBLY DUE TO THE MIGRATION OF THE STENT THROUGH THE FISTULA INTO THE BRONCHIAL TREE, LEADING TO A PNEUMOTHORAX. AN AUTOPSY WAS NOT PERFORMED. PER THE PHYSICIAN, THE GUIDEWIRE AND C.R.E. DILATATION BALLOON USED DURING THE PROCEDURE WORKED AS EXPECTED AND NO ISSUES WERE ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX¿ ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516700 15612756

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R