BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL

    MDR report key: 21389119 · Received February 14, 2025

    Report

    Report Number
    3005099803-2025-00472
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    November 6, 2024
    Report Date
    February 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    PMA / PMN Number
    K091510
    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

    BLOCK A4: PATIENT WEIGHT IS 67.6 KG; REPORTED HERE AS THE PATIENT WEIGHT EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K)#: K091510, K233939; REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E1020 CAPTURES THE REPORTABLE EVENT OF NAUSEA. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF PRESSURE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF STENT WAS NOTED TO HAVE MIGRATED AS SEEN ON THE X-RAY. IMDRF DEVICE CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE STENT WAS REMOVED USING GRASPERS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT ESOPHAGEAL STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY IMPLANTED. HOWEVER, ON (B)(6) 2024, THE PATIENT EXPERIENCED PRESSURE, PAIN, AND NAUSEA. ON (B)(6) 2024, IT WAS NOTED THAT THE STENT HAD MIGRATED, AS SEEN ON THE X-RAY. THE MIGRATED STENT WAS THEN REMOVED USING GRASPERS, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN DECIDED TO NOT IMPLANT A NEW STENT THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982723 WALLFLEX ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00516700 0032254984

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention