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

Catalog Number	90129-202/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that a trachobronical stent was placed in a 58-year-old male due to tracheal stenosis.5 months post stent placement, the patient suffered from dyspnea.He was readmitted with severe dyspnea due to collapse of the distal portion of the stent caused by tumor growth.Because stent removal was difficult because of granulation, an additional stent was placed to cover the collapsed portion.The additional stent successfully expanded the collapse and improved his dyspnea.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: AERO®
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 18646327
• Report Number: 3010665433-2024-00013
• Device Sequence Number: 17938855
• Product Code: JCT
• UDI-Device Identifier: 00884450030776
• UDI-Public: 00884450030776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: 90129-202/C
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 58 YR
• Patient Sex: Male