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

Model Number	M00513730
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in mid esophagus stricture to treat an esophageal cancer during an esophagus stricture procedure performed on (b)(6) 2025.During the procedure, the stent partially deployed.The procedure was completed using another ultraflex.There was no patient complications were reported due to this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Additional Manufacturer Narrative
Block d7a (sud reprocessed and reused?) has been corrected.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: the ultraflex? esophageal ng distal covered stent and its delivery system were not returned for analysis; therefore, a technical evaluation could not be conducted.A media inspection of a photo provided by the complainant revealed that the stent was partially deployed.However, due to insufficient evidence and the inability to properly evaluate the device, the most probable causes contributing to the event remain unknown.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in mid esophagus stricture to treat an esophageal cancer during an esophagus stricture procedure performed on (b)(6) 2025.During the procedure, the stent partially deployed.The procedure was completed using another ultraflex.There was no patient complications were reported due to this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an ultraflex esophageal stent was returned for analysis.A visual examination of the returned device revealed that the stent was partially deployed.During functional testing, the stent was deployed and expansion issues were found.Based on the photo provided by the complainant, it can be seen that the stent was partially deployed.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent partially deployed.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely due to procedural factors such as lesion characteristics, device handling, and the technique used by the physician, which could have resulted to the stent being partially deployed.Also, stent expansion rates can be negatively impacted by compression, time, temperatures, and humidity.For this reason, this will be classified as unable to exclude device problem.Based on all the available information, the selected most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in mid esophagus stricture to treat an esophageal cancer during an esophagus stricture procedure performed on (b)(6) 2025.During the procedure, the stent partially deployed.The procedure was completed using another ultraflex.There was no patient complications were reported due to this event.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• 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: 22342525
• Report Number: 3005099803-2025-02970
• Device Sequence Number: 20059017
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)260508(10)33988776
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 05/08/2026
• Device Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0033988776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2025
• Supplement Date Received by Manufacturer: 07/04/2025; 01/30/2026
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/30/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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