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

Catalog Number 90129-202/C

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Dyspnea (1816)

Event Date 09/16/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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®
• Type of Device: 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
• MDR Text Key: 334620218
• Report Number: 3010665433-2024-00013
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00884450030776
• UDI-Public: 00884450030776
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 90129-202/C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male