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

Model Number	M00517770
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code f2301 captures the additional device used to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was intended to be implanted in the distal esophagus to treat a malignant stricture during an esophagogastroduodenoscopy (egd) performed on (b)(6) 2025.The patient's esophageal anatomy was described as tortuous, and no dilation was performed prior to stent placement.The lesion measured approximately 8 cm in length and was noted to be so narrow that only a slim egd scope could barely traverse it.During the procedure, the stent was deployed from the catheter; however, it did not fully expand upon release.Because of the incomplete expansion, the stent remained partially engaged with the delivery system and snagged on the catheter during withdrawal, resulting in the stent being unintentionally pulled out of the patient.A re-sheathing attempt was performed, but the stent continued to catch on the catheter upon exit.The issue prolonged the procedure by approximately fifteen minutes.The stent was ultimately deployed and removed using rescue retrieval forceps, and the procedure was successfully completed using a larger agile esophageal stent.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: 23753496
• Report Number: 3005099803-2025-06645
• Device Sequence Number: 14958400
• Product Code: ESW
• UDI-Device Identifier: 00191506006648
• UDI-Public: (01)00191506006648(17)270609(10)36707918
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/09/2025

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
• Device Lot Number: 0036707918
• 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: 11/11/2025
• Initial Report FDA Received Date: 12/09/2025
• Date Device Manufactured: 06/09/2025
• 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