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

Model Number	M00517250
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal tts partially covered stent was implanted on (b)(6) 2026.During the procedure, an agile partially covered stent was deployed in the patient.However, based on the physician assessment, the stent appeared to be fully covered.A mantis clip was used to secure the stent in case of migration.The physician believes that a fully covered agile stent was incorrectly packaged in a partially covered agile stent box.The stent remained implanted, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a2101 captures the reportable event of device labeling issue block h11: investigation results: boston scientific corporation could not confirm the reported event of device labeling issue.The device was not returned; therefore, product analysis could not be performed.However, a media analysis was performed based on the photo provided by the complainant, and it was observed that the stent was in the patient's anatomy but it was not possible to determine whether the stent was fully covered or partially covered.The investigation findings do not lead to a clear conclusion about the cause of the reported event; therefore, the most probable cause was unable to be established.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.However, a media inspection of the photographs provided by the complainant show evidence that the stent was deployed in the patient anatomy.Based on the available images, it was not possible to determine whether the stent was fully covered or partially covered.Risk review: a risk review was completed and confirmed that the event of "device labeling issue" 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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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 ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24811374
• Report Number: 3005099803-2026-01251
• Device Sequence Number: 9601193
• Product Code: ESW
• UDI-Device Identifier: 08714729972952
• UDI-Public: (01)08714729972952(17)270701(10)36872351
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K233837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: M00517250
• Device Catalogue Number: M00517250
• Device Lot Number: 0036872351
• 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: 03/09/2026
• Initial Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 07/01/2025
• 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