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

Model Number	M00517460
Medical Device Problem Codes	Device-Device Incompatibility (2919); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to an agile esophageal stent and overstitch nxt used during the same procedure.It was reported to boston scientific corporation that an agile esophageal fully covered tts stent was attempted to be implanted during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2026.During the procedure, the agile stent was successfully placed; however, during scope removal, the stent became caught on the overstitch needle driver and had to be forcibly removed.The procedure was completed using another agile esophageal tts stent.There were no patient complications associated with this event and the patient condition following the procedure was reported as stable.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

• 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: 50334618
• Report Number: 3005099803-2026-03414
• Device Sequence Number: 17510107
• Product Code: ESW
• UDI-Device Identifier: 08714729973089
• UDI-Public: (01)08714729973089(17)280226(10)38697435
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K233837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: M00517460
• Device Catalogue Number: M00517460
• Device Lot Number: 0038697435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 02/26/2026
• 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