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

Model Number	M00517720
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device a1502 code captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal partially covered stent was to be implanted in the esophagus to treat esophageal cancer during an esophagogastroduodenoscopy (egd) procedure performed on december 1, 2025.The patient's anatomy was tortuous (tight) and was not dilated prior to stent placement.During the procedure, it was reported that the physician was not pleased with the placement of the 10cm agile esophageal stent as it "jumped" forward upon placement and was not able to reposition correctly.The stent was then removed with rat tooth forceps.The procedure was completed with another stent of the same model but with a longer size.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: 23935704
• Report Number: 3005099803-2025-06966
• Device Sequence Number: 15814547
• Product Code: ESW
• UDI-Device Identifier: 00191506006594
• UDI-Public: (01)00191506006594(17)270403(10)36218750
• 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: 2025
• Device Explanted Year: 2025
• 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): 12/31/2025

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: M00517720
• Device Catalogue Number: M00517720
• Device Lot Number: 0036218750
• 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: 12/05/2025
• Initial Report FDA Received Date: 12/31/2025
• Date Device Manufactured: 04/03/2025
• 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