BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL

    MDR report key: 14454886 · Received May 20, 2022

    Report

    Report Number
    3005099803-2022-02672
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    October 1, 2006
    Report Date
    May 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE MONTH AND YEAR THE FIRST PROCEDURES WERE PERFORMED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. LITERATURE SOURCE: THOMAS, S., SIDDIQUI, A., TAYLOR, L. J., PARBHU, S., CAO, C., LOREN, D., KOWALSKI, T., ADLER, D. FULLY-COVERED ESOPHAGEAL STENT MIGRATION RATES IN BENIGN AND MALIGNANT DISEASE; A MULTICENTER RETROSPECTIVE STUDY. ENDOSCOPY INTERNATIONAL OPEN 2019; 7(6): E751-E756. HTTPS://DOI.ORG/10.1055/A-0890-3284. (B)(4).

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS THROUGH THE ARTICLE "FULLY-COVERED ESOPHAGEAL STENT MIGRATION RATES IN BENIGN AND MALIGNANT DISEASE: A MULTICENTER RETROSPECTIVE STUDY" BY DR. DOUGLAS G. ADLER, ET AL. BOSTON SCIENTIFIC WALLFLEX ESOPHAGEAL FULLY COVERED STENTS AND TWO TYPES OF NON-BOSTON SCIENTIFIC (ENDOMAXX AND EVOLUTION) STENTS WERE USED DURING THE STUDY. THE STENTS WERE PLACED TO TREAT BENIGN AND MALIGNANT STRICTURES DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURES PERFORMED BETWEEN OCTOBER 2006 AND AUGUST 2016. 369 PATIENTS WERE INCLUDED IN THE STUDY, WITH 161 WHOM HAD BENIGN STRICTURES AND 208 WHOM HAD MALIGNANT STRICTURES. FOR THE 161 CASES OF BENIGN STRICTURES, 94 WALLFLEX ESOPHAGEAL STENTS WERE IMPLANTED WHILE 67 NON-BOSTON SCIENTIFIC ESOPHAGEAL STENTS (47 ENDOMAXX STENTS AND 20 EVOLUTION STENTS) WERE IMPLANTED. FOR THE 208 CASES OF MALIGNANT STRICTURES, 124 WALLFLEX ESOPHAGEAL STENTS WERE IMPLANTED WHILE 84 NON-BOSTON SCIENTIFIC ESOPHAGEAL STENTS (49 ENDOMAXX STENTS AND 35 EVOLUTION STENTS) WERE IMPLANTED. ACCORDING TO THE LITERATURE, A TOTAL OF 32 STENTS PLACED FOR BENIGN STRICTURES WERE NOTED TO HAVE A LATE COMPLICATION THAT REQUIRED STENT REPLACEMENT. TWENTY-EIGHT STENTS WERE REMOVED AND REPLACED DUE TO STENT MIGRATION. THE 4 REMAINING STENTS WERE REPLACED DUE TO ESOPHAGEAL PERFORATION, STENT OCCLUSION, CHEST PAIN, AND NON-DEFINED COMPLICATION. IN ADDITION, A TOTAL OF 30 STENTS PLACED FOR MALIGNANT STRICTURES WERE NOTED TO HAVE A LATE COMPLICATION THAT REQUIRED STENT REPLACEMENT. TWENTY-FIVE STENTS WERE REMOVED AND REPLACED DUE TO STENT MIGRATION. THE 5 REMAINING STENTS WERE REPLACED DUE TO 2 STENTS BEING OCCLUDED, 2 NON-DEFINED COMPLICATIONS, AND THE OTHER ONE ENCOUNTERED CHEST PAIN. NOTE: IT IS UNKNOWN WHETHER THE BOSTON SCIENTIFIC WALLFLEX ESOPHAGEAL STENTS OR THE TWO TYPES OF NON-BOSTON SCIENTIFIC (ENDOMAXX AND EVOLUTION) STENTS ENCOUNTERED THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470391 WALLFLEX ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention