MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX? TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	M00576570
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 captures the reportable event of the stent was pulled and another stent was used to address the event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the main bronchial to treat a narrowing in the airway for more lung volume during a tracheobronchial stent placement performed on (b)(6) 2025.The patient was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was able to be released from the delivery system.However, the stent did not look right and was still smashed down, and the stent did not expand off the delivery system.The physician was able to pull the stent and placed another tracheobronchial stent to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5 and h6 (device code) were corrected following a medical review which determined that the stent was used for benign indication.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 captures the reportable event of the stent was pulled and another stent was used to address the event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the main bronchial to treat a narrowing in the airway for more lung volume during a tracheobronchial stent placement performed on (b)(6) 2025.The patient was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was able to be released from the delivery system.However, the stent did not look right and was still smashed down, and the stent did not expand off the delivery system.The physician was able to pull the stent and placed another tracheobronchial stent to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the stent was to be implanted in a benign indication, and there was no malignancy at the site.However, per the ultraflex tracheobronchial stent system directions for use, the stent is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.The device is not indicated to be implanted for benign indication.

• Brand Name: ULTRAFLEX? TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 23696074
• Report Number: 3005099803-2025-06319
• Device Sequence Number: 21100318
• Product Code: JCT
• UDI-Device Identifier: 08714729842378
• UDI-Public: (01)08714729842378(17)261021(10)35106273
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00576570
• Device Catalogue Number: M00576570
• Device Lot Number: 0035106273
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 10/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown