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

Model Number	M00517450
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of additional device required to remove the migrated stent.
Event or Problem Description
It was reported to boston scientific corporation that a agile esophageal tts fully covered stent was to be implanted, procedure performed on (b)(6) 2025.It was reported that a complete distal stent migration occurred.There were no patient complications reported as a result of this event.No additional information has been obtained despite good faith effort.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal tts fully covered stent was implanted during a procedure performed on (b)(6) 2025.It was reported that a complete distal stent migration occurred on (b)(6) 2025.There were no patient complications reported as a result of this event.No additional information has been obtained despite good faith effort.
Additional Manufacturer Narrative
Corrected fields: block b1 (adverse event/product problem).Blocks b5 (describe event or problem).Block d6a (implant date).Block e1 (initial reporter email).Block h1 (type of reportable event).Block h6 (impact codes).Block h6: imdrf device code a010402 captures the reportable event of stent migration.

• 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: 22854359
• Report Number: 3005099803-2025-04137
• Device Sequence Number: 14574786
• Product Code: ESW
• UDI-Device Identifier: 08714729973072
• UDI-Public: (01)08714729973072(17)260521(10)34079657
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K233837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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 Expiration Date: 05/21/2026
• Device Model Number: M00517450
• Device Catalogue Number: M00517450
• Device Lot Number: 0034079657
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 05/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown