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

Model Number	M00517730
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0104002 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of additional device required to remove the migrated stent.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Block h11: investigation results: boston scientific corporation could not confirm the reported event of stent migration.The device was not returned; therefore, product analysis could not be performed.Based on the information available there is no clinical or technical evidence to determine whether the patient reports symptoms were due to a device malfunction or structural compromise, and without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which have contributed to the reported event device technical analysis: the device was not returned; therefore, product analysis could not be performed.Risk review: a risk review was completed and confirmed that the event of "stent migration, pain, hospitalization or prolonged hospitalization, endoscopic procedure and additional device required" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: a labeling review was performed and, from the information available, there is no information that the device was used in a manner inconsistent with the instructions for use (ifu) as a known possible adverse event related to the use of the device.Additionally, it was confirmed that the following adverse events are anticipated in the ifu: stent migration and pain.Investigation conclusion: based on the available information, there is not enough evidence to confirm the cause of reported event.Without proper evaluation of the complaint device, cause not established is selected as the investigation conclusion code.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal otw stent was implanted to treat distal esophageal cancer during an esophagogastroduodenoscopy (egd) with stent placement on (b)(6) 2026.It was reported that the stent was successfully deployed but migrated approximately two weeks after implantation.The patient experienced discomfort due to pain.The migrated stent was removed using rescue forceps, and a longer agile esophageal otw stent was placed to complete the procedure.

• Brand Name: Agile? 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: 25474163
• Report Number: 3005099803-2026-02421
• Device Sequence Number: 16058889
• Product Code: ESW
• UDI-Device Identifier: 00191506006600
• UDI-Public: (01)00191506006600(17)270410(10)36271395
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K233837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00517730
• Device Catalogue Number: M00517730
• Device Lot Number: 0036271395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 07/12/2026; 09/08/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 08/05/2026; 10/02/2026
• Date Device Manufactured: 04/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown