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

Model Number	M00513750
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
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 distal release covered stent was to be implanted in the esophagus to treat a 9cm stricture due to esophageal cancer during an esophageal stenting procedure performed on march 6, 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was attempted to be deployed; however, the thread got stuck, and the stent was unable to be fully deployed.The stent was removed from the patient partially deployed and another ultraflex esophageal stent was used to complete 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.Block h11: an ultraflex esophageal distal release covered stent was received for analysis.The stent was returned partially deployed.Visual examination found the suture was knotted.Functional test related to the deployment could not be performed.No other damages were noted to the device.Product analysis confirmed the reported event of a partially deployed stent.Procedural factors such as lesion characteristics, device handling, and the technique used by the physician were the most likely contributors to the damage observed on the device.These damages may have prevented full deployment of the stent during the procedure, resulting in the partial deployment noted during product analysis.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted in the esophagus to treat a 9cm stricture due to esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was attempted to be deployed; however, the thread got stuck, and the stent was unable to be fully deployed.The stent was removed from the patient partially deployed and another ultraflex esophageal stent was used to complete 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: 21731225
• Report Number: 3005099803-2025-01344
• Device Sequence Number: 15652877
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: (01)08714729649113(17)260726(10)34513762
• 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 Expiration Date: 07/26/2026
• Device Model Number: M00513750
• Device Catalogue Number: M00513750
• Device Lot Number: 0034513762
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 52 KG