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

Model Number	M00513730
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a4 (weight) is 63.5 kg, reported here as it exceeded the maximum character limit of the designated field.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng stent system was to be implanted in the esophagus to treat 7cm esophageal stenosis during an esophageal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tight prior to stent placement.During the procedure, the front end of the stent had expanded before deployment and could not cross the stenosis.The stent was removed together with the delivery system.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng stent system was to be implanted in the esophagus to treat 7cm esophageal stenosis during an esophageal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tight prior to stent placement.During the procedure, the front end of the stent had expanded before deployment and could not cross the stenosis.The stent was then removed together with the delivery system.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a4 (weight) is 63.5 kg, reported here as it exceeded the maximum character limit of the designated field.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf device code a150101 captures the reportable event of stent expansion failure based on investigation.Block h11: an ultraflex esophageal covered stent and delivery system were received for analysis.The stent was returned partially deployed.Functional inspection found the stent was deployed with no resistance felt, but with expansion problem.No other damage was noted to the device.Product analysis confirmed the reported event of stent partially deployed.The investigation concluded that the damages found in the device was most likely due to procedure factors such as lesion characteristics, handling of the device, and the technique used by the physician that could have resulted to the stent being unable to deploy during the procedure.Additionally, the expansion failure has insufficient evidence to determine whether it contributed to the event.Stent expansion rates can be negatively impacted by factors including 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.Based on all available information, the investigation selected that the most probable cause is adverse event related to procedure.

• 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: 23033496
• Report Number: 3005099803-2025-04598
• Device Sequence Number: 13216597
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)260307(10)33581682
• 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,Followup
• Report Date (Section B): 11/25/2025

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: 03/07/2026
• Device Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0033581682
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 11/02/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 63 KG