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

Model Number	M00513750
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted to treat a stricture in the mid esophageal during an esophageal stenting procedure performed on (b)(6) 2026.During the procedure, approximately 95 percent of the stent was successfully deployed and expanded well.However, during the final stage of deployment, when the physician attempted to expand the remaining 5 percent of the stent, it failed to open as expected.The device was subsequently removed from the system, after which the stent expanded normally outside the patient.Another ultraflex esophageal stent was used to complete the procedure.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.
Additional Manufacturer Narrative
Block b5 and h6 (device code) has been updated with the additional information received on january 20, 2026.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf device code a0401 captures the reportable event of suture break.Block h11: an ultraflex esophageal stent was not returned for analysis.A media inspection was performed using the photographs provided by the complainant.Based on the images, there is evidence that the device was missing its suture and missing the stent component.The photographs also show the original product pouch with its corresponding label, including the involved lot number and upn.No other damages were noted to the stent and delivery system.Product analysis could not confirm the reported event of stent partially deployed and stent suture break through physical evaluation, as the device was not returned for analysis.Based on the event description and the information provided by the customer, there is insufficient evidence to determine whether the stent partially deployed and stent suture break events were due to physician manipulation/technique during the procedure or related to a device malfunction.The investigation concluded that without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Therefore, due to the lack of evidence and without proper evaluation of the complaint device, unable to exclude device problem is selected as the most probable root cause.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted to treat a stricture in the mid esophageal during an esophageal stenting procedure performed on (b)(6) 2026.During the procedure, approximately 95 percent of the stent was successfully deployed and expanded well.However, during the final stage of deployment, when the physician attempted to expand the remaining 5 percent of the stent, it failed to open as expected.The device was subsequently removed from the system, after which the stent expanded normally outside the patient.Another ultraflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.***additional information received on january 20, 2026.*** it was reported that the tread of the stent breaks down unable to release the stent.

• 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: 24184916
• Report Number: 3005099803-2026-00307
• Device Sequence Number: 15833738
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: (01)08714729649113(17)270324(10)36132896
• 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
• Report Date (Section B): 02/12/2026

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: 0036132896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 79 KG