BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL

    MDR report key: 21048435 · Received December 31, 2024

    Report

    Report Number
    3005099803-2024-06686
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729778073
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGO-GASTRIC JUNCTION (OGJ) TO TREAT AN APPROXIMATELY 6CM MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED, AND THE DELIVERY SYSTEM WAS REMOVED; HOWEVER, IT WAS NOTED THAT THE STENT WAS PLACED PROXIMAL TO THE STRICTURE. SUBSEQUENTLY, THE STENT WAS PUSHED DOWN USING A GRASPER, BUT IT WAS UNSUCCESSFUL. THE STENT WAS THEN REMOVED WITH THE SAME GRASPER. THE PROCEDURE WAS CANCELLED AS THE PHYSICIAN DECIDED NOT TO PLACE ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782790 WALLFLEX ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00516740 0033328321 08714729778073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention