MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX? ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number	M00516900
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was used to treat a 7cm malignant esophageal stricture in the esophagus during a metal stenting procedure performed on (b)(6) 2025.The patient's anatomy was very tight and was dilated prior to stent placement.During the procedure, the physician tried to open the stent multiple times, but it failed to deploy.Consequently, the procedure was cancelled.No further procedures are planned.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f2301 captures the reportable event of a cancelled/rescheduled procedure.

• 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 ; EI
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22958022
• Report Number: 3005099803-2025-04258
• Device Sequence Number: 9591213
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: (01)08714729765240(17)250825(10)32089148
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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 Expiration Date: 08/25/2025
• Device Model Number: M00516900
• Device Catalogue Number: M00516900
• Device Lot Number: 0032089148
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 07/26/2023
• 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: Male