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

Model Number	M00513750
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal covered stent was used in the esophagus to treat an 8cm malignant esophageal stenosis during an esophageal stenosis dilation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous (tight) and was dilated prior to stent placement.During the procedure, it was reported that the stent could not be released.It was noted that the stent was partially deployed when it was removed from the patient.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 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 covered stent was attempted to be implanted in the esophagus to treat an 8cm malignant esophageal stenosis during an esophageal stenosis dilation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous (tight) and was dilated prior to stent placement.During the procedure, it was reported that the stent could not be released.It was noted that the stent was partially deployed when it was removed from the patient.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 h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an ultraflex esophageal stent was returned for analysis.Visual examination of the returned device observed it to be fully expanded and deployed.No abnormalities were noted to the stent or delivery system.Product analysis did not confirm the reported event of stent partially deployed.The device was returned with the stent fully expanded and deployed and no abnormalities were found on it.Examination of the returned device did not reveal evidence of the alleged malfunction or any other defect.Based on the available information and findings from the device evaluation, the most probable cause is determined to be device problem excluded.

• 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: 23717667
• Report Number: 3005099803-2025-06327
• Device Sequence Number: 8845998
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: (01)08714729649113(17)270207(10)35804849
• 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): 02/24/2026

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 Model Number: M00513750
• Device Catalogue Number: M00513750
• Device Lot Number: 0035804849
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 64 KG