BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILE? ESOPHAGEAL

    MDR report key: 22854359 · Received August 20, 2025

    Report

    Report Number
    3005099803-2025-04137
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    April 7, 2025
    Report Date
    December 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729973072
    PMA / PMN Number
    K233837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: BLOCK B1 (ADVERSE EVENT/PRODUCT PROBLEM). BLOCKS B5 (DESCRIBE EVENT OR PROBLEM). BLOCK D6A (IMPLANT DATE). BLOCK E1 (INITIAL REPORTER EMAIL). BLOCK H1 (TYPE OF REPORTABLE EVENT). BLOCK H6 (IMPACT CODES). BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED TO REMOVE THE MIGRATED STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL TTS FULLY COVERED STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT A COMPLETE DISTAL STENT MIGRATION OCCURRED ON (B)(6) 2025. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AGILE ESOPHAGEAL TTS FULLY COVERED STENT WAS TO BE IMPLANTED, PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT A COMPLETE DISTAL STENT MIGRATION OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243712 AGILE? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00517450 0034079657 08714729973072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention