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

Model Number	M00513730
Medical Device Problem Codes	Positioning Failure (1158); 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	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable investigation finding of stent partially deployed.Block h11: an ultraflex esophageal stent with its delivery system was returned for analysis.Visual examination of the returned device identify that the stent was partially deployed.Functional testing for stent deployment was performed by pulling the finger ring, and the stent deployed without resistance.However, expansion issues were observed.Product analysis confirmed the reported event of stent failure to deploy.The investigation concluded that the deployment issue was most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).As for the expansion issue noticed, expansion rates can be negatively impacted by the following factors: compression, time, temperature, and humidity.Slow expansion rates are seen most predominantly in the largest stent sizes, which experience the highest compression conditions while in the catheter delivery system.The larger the stent diameter, the more it is "packed" into the catheter of the delivery system.This means the stent will be compressed more and is more likely to have an unconstrained opening dimension that is smaller than the manufacturing specification.Therefore, a review and analysis of all the available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted in the esophagus to treat esophageal stenosis during a stent placement procedure performed on (b)(6) 2025.During the procedure, the stent could not be deployed.Another ultraflex esophageal stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent partially deployed.Please see block h11 for full investigation details.

• 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: 23675582
• Report Number: 3005099803-2025-06524
• Device Sequence Number: 15877897
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)260126(10)33300922
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/28/2025

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: 01/26/2026
• Device Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0033300922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 67 KG