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

Model Number	M00514250
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
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 stent was to be implanted in the esophagus to treat a benign esophageal stricture during an ultraflex esophageal stenting procedure performed on (b)(6) 2025.During the procedure, the stent partially deployed.The procedure was completed using another ultraflex esophageal stent.There was no patient complications reported as a result of this event, the patient condition was reported to be stable.Note: it was reported that the ultraflex esophageal stent was used to treat a benign esophageal stricture.However, per the ultraflex esophageal ng stent system stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.The device is not indicated for the treatment of benign esophageal stricture.
Additional Manufacturer Narrative
B5 has been updated with additional information received on 03jun2025.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 stent was to be implanted in the esophagus to treat a benign esophageal stricture during an ultraflex esophageal stenting procedure performed on (b)(6) 2025.During the procedure, the stent partially deployed.The procedure was completed using another ultraflex esophageal stent.There was no patient complications reported as a result of this event, the patient condition was reported to be stable.Note: it was reported that the ultraflex esophageal stent was used to treat a benign esophageal stricture.However, per the ultraflex esophageal ng stent system stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.The device is not indicated for the treatment of benign esophageal stricture.Additional information received on 03jun2025: the stent was not inserted through the working channel, the technique used was the over-the-wire system.It did not open during the deployment phase.It seemed to be stuck within its own delivery system and only a very small portion of it was opening.Additionally, the patient's anatomy was not tight, and no dilation was performed prior to stent placement.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22207938
• Report Number: 3005099803-2025-02665
• Device Sequence Number: 15123967
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: (01)08714729716112(17)260211(10)33402150
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/22/2025

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: 02/11/2026
• Device Model Number: M00514250
• Device Catalogue Number: M00514250
• Device Lot Number: 0033402150
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 02/12/2024
• 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 Sex: Unknown