BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILE ESOPHAGEAL

    MDR report key: 21020784 · Received December 26, 2024

    Report

    Report Number
    3005099803-2024-06619
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    00191506006655
    PMA / PMN Number
    K211960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT DATE OF BIRTH IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT HE WAS BORN IN 1947. BLOCK A4: PATIENT'S WEIGHT: 85.3 KILOGRAMS - REPORTED HERE AS IT EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET 510(K): K211960, K233837 - REPORTED HERE AS IT EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A010402 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF STENT MIGRATION.

    Additional Manufacturer Narrative · 0

    BLOCK A1: (B)(6) PATIENT'S IDENTIFIER HAS BEEN UPDATED. BLOCK A2: PATIENT'S EXACT DATE OF BIRTH IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT HE WAS BORN IN 1947. BLOCK A4: PATIENT'S WEIGHT: 85.3 KILOGRAMS - REPORTED HERE AS IT EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET 510(K): K211960, K233837 - REPORTED HERE AS IT EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A010402 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF STENT MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OVER-THE-WIRE STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT-APPEARING, INTRINSIC, MODERATE ULCERATED STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, COMPLETE PROXIMAL STENT MIGRATION OCCURRED. REPORTEDLY, THE STRICTURE WAS NOT RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OVER-THE-WIRE STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT-APPEARING, INTRINSIC, MODERATE ULCERATED STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, COMPLETE PROXIMAL STENT MIGRATION OCCURRED. REPORTEDLY, THE STRICTURE WAS NOT RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494500 AGILE ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00517780 0033719985 00191506006655

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male