MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. AEROMINI®.STENT, TRACHEOBRONCHIAL STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Catalog Number	AERO615/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges that during a tracheobronchial stent deployment procedure, the distal end of the stent had fractured.The stent was successfully removed from the patient, and a new stent was deployed.No additional patient consequences to report.

• Brand Name: AEROMINI®.STENT, TRACHEOBRONCHIAL STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby dr,; pearland TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby dr,; pearland TX 77047
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21175222
• Report Number: 3010665433-2025-00002
• Device Sequence Number: 12912169
• Product Code: JCT
• UDI-Device Identifier: 00884450710302
• UDI-Public: 884450710302
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K181200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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 Catalogue Number: AERO615/A
• Device Lot Number: E2936786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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