BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1625871 · Received March 9, 2010

    Report

    Report Number
    3005099803-2010-01155
    Event Type
    Death
    Date Received
    March 9, 2010
    Report Date
    February 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE HAS NOT BEEN RETURNED, BOSTON SCIENTIFIC CORPORATION COULD NOT PERFORM A TECHNICAL ANALYSIS. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF DEATH IS UNKNOWN; HOWEVER IT IS ESTIMATED TO BE (B) (6) 2010. THE EXACT DATE OF IMPLANTATION IS UNKNOWN; HOWEVER IT IS ESTIMATED TO BE (B) (6) 2010. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX FULLY COVERED ESOPHAGEAL STENT WAS USED DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE TO TREAT AN ESOPHAGEAL STRICTURE, PERFORMED BETWEEN APPROXIMATELY (B) (6), 2010. ACCORDING TO THE COMPLAINANT, SEVERAL WEEKS POST STENT IMPLANTATION, THE PATIENT DEVELOPED A TRACHEOESOPHAGEAL FISTULA. IT WAS UNKNOWN IF THE STENT CONTRIBUTED TO THE DEVELOPMENT OF THE FISTULA. THE PATIENT SUBSEQUENTLY DIED. THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR HIV (HUMAN IMMUNODEFICIENCY VIRUS). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS EVENT. THE PHYSICIAN STATED THAT THE STENT WAS PLACED HIGH IN THE ESOPHAGUS AND THE PATIENT HAD DIFFICULTY BREATHING AFTER THE PROCEDURE. THE DEVELOPMENT OF THE TRACHEOESOPHAGEAL FISTULA HAPPENED A FEW DAYS LATER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX FULLY COVERED ESOPHAGEAL STENT WAS USED DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE TO TREAT AN ESOPHAGEAL STRICTURE, PERFORMED BETWEEN APPROXIMATELY (B) (6) 2010. ACCORDING TO THE COMPLAINANT, SEVERAL WEEKS POST STENT IMPLANTATION, THE PATIENT DEVELOPED A TRACHEOESOPHAGEAL FISTULA. IT WAS UNKNOWN IF THE STENT CONTRIBUTED TO THE DEVELOPMENT OF THE FISTULA. THE PATIENT SUBSEQUENTLY DIED. THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR HIV (HUMAN IMMUNODEFICIENCY VIRUS). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL 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
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY UNK477

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death