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

Model Number	M00517770
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of the stent was removed, and a different device was used.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal fully covered stent otw was to be implanted in the esophagus to treat a stricture during an esophageal stent placement procedure performed on (b)(6) 2025.During the procedure, the agile stent was deployed and was in good position.However, within a few minutes of deployment, the stent migrated into the stomach.The stent was subsequently removed, and a different device was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 23536674
• Report Number: 3005099803-2025-05921
• Device Sequence Number: 16003049
• Product Code: ESW
• UDI-Device Identifier: 00191506006648
• UDI-Public: (01)00191506006648
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K233837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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 Model Number: M00517770
• Device Catalogue Number: M00517770
• 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: 10/20/2025
• Initial Report FDA Received Date: 11/12/2025
• 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