MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. AERO®; TRACHEOBRONCHIAL STENT

Catalog Number	90129-210/G
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while deploying the tracheobronchial stent, the delivery system failed and the distal tapered white tip broke off.The broken tip was retrieved from the patient.No patient harm reported.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

• Brand Name: AERO®
• Common Device Name: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 25033730
• Report Number: 3010665433-2026-00003
• Device Sequence Number: 15683404
• Product Code: JCT
• UDI-Device Identifier: 00884450703991
• UDI-Public: 00884450703991
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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
• Device Catalogue Number: 90129-210/G
• Device Lot Number: E3324331
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown