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

Model Number	M00513740
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	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf impact code f1001 captures the reportable event of cancelled/rescheduled - post sedation/sedation unknown.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted to the esophagus to treat an 8cm size of lesion caused by malignancy during an endoscopy guided esophageal stenting procedure performed on (b)(6) 2026.The anatomy of the patient was not tortuous and was not dilated prior to stent placement.During procedure, while placing the stent, the stent deployment suture thread broke down while pulling the thread.When the stent was removed from the patient, it was partially deployed.Due to this event, the stent was not implanted.Initially, the procedure was not completed.However, on the day after, the procedure was completed using a different device.There were no patient complications reported as a result of the procedure.There was 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.Imdrf impact code f1001 captures the reportable event of cancelled/rescheduled - post sedation/sedation unknown.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent partially deployed cancelled/rescheduled - post sedation/sedation unknown.The device has not been returned for product evaluation; therefore, a technical analysis could not be performed.Based on the information available and without proper evaluation of the device, it is unknown if the reported events were due to the physician's technique during the procedure, or whether it was related to a device malfunction.Device history review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the complaint device was not returned for evaluation; therefore, a technical analysis could not be performed.However, media analysis was performed on provided pictures, and it can be observed the product packaging, a customer letter, and the stent fully deployed outside the patient.Risk review: a risk review of the ultraflex esophageal stents was completed and confirmed that the events of stent deployment suture break stent partially deployed and cancelled/rescheduled - post sedation/sedation unknown were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted to the esophagus to treat an 8cm size of lesion caused by malignancy during an endoscopy guided esophageal stenting procedure performed on (b)(6) 2026.The anatomy of the patient was not tortuous and was not dilated prior to stent placement.During procedure, while placing the stent, the stent deployment suture thread broke down while pulling the thread.When the stent was removed from the patient, it was partially deployed.Due to this event, the stent was not implanted.Initially, the procedure was not completed.However, on the day after, the procedure was completed using a different device.There were no patient complications reported as a result of the procedure.There was no patient complications reported as a result of this 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: 24274265
• Report Number: 3005099803-2026-00488
• Device Sequence Number: 10722782
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: (01)08714729716167(17)270221(10)35907635
• 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): 03/05/2026

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: M00513740
• Device Catalogue Number: M00513740
• Device Lot Number: 0035907635
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 02/21/2025
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 147 LB