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

Model Number	M00514200
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted during a procedure performed on (b)(6) 2025.During procedure, the stent was difficult to release even after pulling the thread to begin release.When the stent was retracted during delivery removal, it was partially retracted.Eventually, the stent suddenly released making it difficult to place it in the intended location.The procedure was completed using a proximal release version of the same device.There were no patient complications reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment imdrf impact code f2301 captures the reportable event of additional device required.Block h11: an axios stent was received for analysis.The handle was not returned.Only the stent was returned.A visual examination of the returned device found the stent fully expanded and deployed.No other problems were noted with the stent.The product analysis could not confirm the reported event of stent premature deployment, as only the stent was returned, and the handle was not provided.The analysis found that the stent was fully expanded and deployed.Additionally, the reported event of additional device required cannot be confirmed because happened during the procedure and there are not an objective evidence or descriptive conditions to establish the cause of the reported event.Considering all available information, the investigation concluded that the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted during a procedure performed on (b)(6) 2025.During procedure, the stent was difficult to release even after pulling the thread to begin release.When the stent was retracted during delivery removal, it was partially retracted.Eventually, the stent suddenly released making it difficult to place it in the intended location.The procedure was completed using a proximal release version of the same device.There were no patient complications reported as a result of the 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: 23556549
• Report Number: 3005099803-2025-06065
• Device Sequence Number: 9646207
• Product Code: ESW
• UDI-Device Identifier: 08714729121190
• UDI-Public: (01)08714729121190(17)270306(10)36002912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: M00514200
• Device Catalogue Number: M00514200
• Device Lot Number: 0036002912
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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