BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ESOPHAGEAL

    MDR report key: 21218619 · Received January 23, 2025

    Report

    Report Number
    3005099803-2025-00099
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729778073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G4: PREMARKET/510(K): K233939, K091510, REPORTED HERE AS THIS EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: 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 IMPLANTED TO TREAT A 5CM STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) ESOPHAGEAL STENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT ANATOMY WAS NOTED TO BE TORTUOUS. DURING THE WITHDRAWAL, AFTER THE STENT DEPLOYED IT WAS CAUGHT ON THE DELIVERY SYSTEM. THEY ADJUSTED AND RECAPTURED SHEATH. ANOTHER WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085336 WALLFLEX ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00516740 08714729778073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose