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

Model Number	M00517760
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal otw stent was to be implanted to treat an esophageal perforation during an esophageal stent placement procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous.During the procedure, the stent was placed.Upon removal of the delivery system the stent became caught on the delivery system.The stent and delivery system were removed together.The procedure was completed with another of the same device.No patient complications were reported as a result of this event.(b)(6) 2025.It was reported that the agile esophageal otw stent was used to treat a benign esophageal perforation.However, per the agile esophageal otw stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The device is not indicated to be placed for treatment of a perforation.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent difficult to removed.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal otw stent was fully implanted to treat an esophageal perforation during an esophageal stent placement procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous.During the procedure, the stent was placed.Upon removal of the delivery system the stent became caught on the delivery system.The stent and delivery system were removed together.The procedure was completed with another of the same device.No patient complications were reported as a result of this event.It was reported that the agile esophageal otw stent was used to treat a benign esophageal perforation.However, per the agile esophageal otw stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The device is not indicated to be placed for treatment of a perforation.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22323546
• Report Number: 3005099803-2025-02698
• Device Sequence Number: 15660957
• Product Code: ESW
• UDI-Device Identifier: 00191506006631
• UDI-Public: (01)00191506006631(11)240730(17)260730(10)34534647
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 07/18/2025

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 Expiration Date: 07/30/2026
• Device Model Number: M00517760
• Device Catalogue Number: M00517760
• Device Lot Number: 0034534647
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 07/30/2024
• 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
• Patient Sex: Unknown