MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Ultraflex? Tracheobronchial; Prosthesis, Tracheal, Expandable

Model Number	M00576330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemoptysis (1887)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific corporation performed a retrospective data analysis on the ultraflex tracheobronchial stent system using the pinc ai healthcare database.Patients were identified through records associated with use of the ultraflex tracheobronchial stent system.The date review period ranges from january 2023 to december 2025.These analyses are being performed as a specific post market clinical follow up (pmcf) activity to assess the safety and performance of the subject device.The pinc ai healthcare database data is de-identified before being transmitted to boston scientific; thus, there are significant limitations to boston scientific's ability to correlate the data to information previously reported to boston scientific.Additionally, event date, event outcome, and initial reporter are not provided in the de-identified data due to the terms of the pinc ai healthcare database.Patient admission date: april 21, 2022.Patient discharge date: august 31, 2022.Adverse event including hemoptysis.The patient underwent endoscopic removal of an intraluminal device from the tracheobronchial tree, followed by endoscopic repair of the right main bronchus and an ultraflex tracheobronchial stent was subsequently placed.Note: imdfr code f08 (hospitalization or prolonged hospitalization), b1 (adverse event), and b2 (hospitalization, initial or prolonged) were selected due to limited available information.Boston scientific is unable to conclude whether the reported event resulted in an extension of the patient's hospitalization or was associated with the planned course of treatment.
Event or Problem Description
Boston scientific corporation performed a retrospective data analysis on the ultraflex tracheobronchial stent system using the pinc ai healthcare database.Patients were identified through records associated with use of the ultraflex tracheobronchial stent system.The date review period ranges from january 2023 to december 2025.These analyses are being performed as a specific post market clinical follow up (pmcf) activity to assess the safety and performance of the subject device.The pinc ai healthcare database data is de-identified before being transmitted to boston scientific; thus, there are significant limitations to boston scientific's ability to correlate the data to information previously reported to boston scientific.Additionally, event date, event outcome, and initial reporter are not provided in the de-identified data due to the terms of the pinc ai healthcare database.Patient admission date: (b)(6) 2022.Patient discharge date: (b)(6) 2022.Adverse event including hemoptysis.The patient underwent endoscopic removal of an intraluminal device from the tracheobronchial tree, followed by endoscopic repair of the right main bronchus and an ultraflex tracheobronchial stent was subsequently placed.Note: imdfr code f08 (hospitalization or prolonged hospitalization), b1 (adverse event), and b2 (hospitalization, initial or prolonged) were selected due to limited available information.Boston scientific is unable to conclude whether the reported event resulted in an extension of the patient's hospitalization or was associated with the planned course of treatment.
Additional Manufacturer Narrative
Block d4, h4: the lot number was not provided.Therefore, the manufacture and expiration dates are unknown.Detailed product information was not provided to boston scientific.Based on the nature of the information provided to boston scientific, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf patient code e0721 captures the reportable event of hemoptysis.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Block h11: this report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.
Additional Manufacturer Narrative
Block d4, h4: the lot number was not provided.Therefore, the manufacture and expiration dates are unknown.Detailed product information was not provided to boston scientific.Based on the nature of the information provided to boston scientific, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf patient code e0721 captures the reportable event of hemoptysis.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event as the device was not returned for analysis.However, hemoptysis is noted within the instructions for use (ifu) as a possible adverse event associated with the use of the device.The investigation concluded that there is not enough evidence to determine whether the reported event of hospitalization or prolonged hospitalization was related to physician technique, procedural factors, the patient's underlying condition, or a potential device malfunction.Without the ability to examine the device, the most probable cause of the event remains unknown.Device history record: a review of the manufacturing documentation and ship history for this device were unable to be performed as the lot number is unknown.Device technical analysis: the complaint device was not returned; therefore, product analysis could not be performed.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, hemoptysis is noted within the instructions for use (ifu) as a known possible adverse event related to the use of the device.Similar complaint review: a similar complaint review was completed.There were no emerging trends identified that warrant further action.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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 ; EI 01752 ; +1(914)571-6918
• MDR Report Key: 50002889
• Report Number: 3005099803-2026-03023
• Device Sequence Number: 18797922
• Product Code: JCT
• UDI-Device Identifier: 08714729837718
• UDI-Public: (01)08714729837718
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00576330
• Device Catalogue Number: M00576330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/10/2026
• 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: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: White