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

Model Number	M00516710
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 is being used to capture the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted in the esophagus to treat a stricture caused by cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2025.During the procedure, it was noticed that the stent had multiple punctures in it.The procedure was then completed with another of the same device.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5, h6 (device codes) and h11 have been updated with the additional information received on february 27, 2025.Block h6: imdrf device code a04 is being used to capture the reportable event of stent cover damaged.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted in the esophagus to treat a stricture caused by cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2025.During the procedure, it was noticed that the stent had multiple punctures in it.The procedure was then completed with another of the same device.There was no patient complication reported as a result of this event.Additional information received on february 27, 2025.It was reported that the wallflex esophageal stent was to be implanted in the esophagus to treat a 3cm malignant stricture.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, it was noted that the lining of the stent was punctured.

• 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: 21554024
• Report Number: 3005099803-2025-00787
• Device Sequence Number: 4643089
• Product Code: ESW
• UDI-Device Identifier: 08714729778042
• UDI-Public: 08714729778042
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 02/13/2026
• Device Model Number: M00516710
• Device Catalogue Number: M00516710
• Device Lot Number: 0034635622
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/27/2025
• Date Device Manufactured: 08/14/2024
• 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