MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WallFlex? Esophageal; Prosthesis, Esophageal

Model Number	M00516930
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex partially covered esophageal stent was to be implanted in the esophagus to treat an esophageal cancer during a gastroscopy procedure performed on (b)(6), 2026.The anatomy was not dilated prior to stent placement.During the procedure, it was noted that the distal end of the stent did not open.The stent was then removed partially deployed on the delivery system, and a different device was used to complete the procedure.There were no patient complications as a result of this event and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.

• Brand Name: WallFlex? Esophageal
• Common Device Name: Prosthesis, Esophageal
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; ballybrit business park; galway H91 Y 868; EI H91 Y868
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50184396
• Report Number: 3005099803-2026-03236
• Device Sequence Number: 10183191
• Product Code: ESW
• UDI-Device Identifier: 08714729765271
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K233939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00516930
• Device Catalogue Number: M00516930
• Device Lot Number: 0036926395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown