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

Catalog Number 90129-201/JPC

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

Patient Problem Abrasion (1689)

Event Date 11/13/2019

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 during a tracheobronchial stent removal procedure, granulation tissues and partial fracture was identified within the struts of the stent.The tracheobronchial stent was implanted in (b)(6) of 2019.The physician states that the fractured contributed to minor tissue damage of trachea's inner wall and a trace amount of bleeding and granulation.Hospital admission necessary for stent removal procedure.The physician is planning on implanting a new tracheobronchial stent in the near future.No serious adverse injury or events to report.

Manufacturer Narrative

The suspect device was not returned for evaluation.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: AERO TRACHEOBRONCHIAL STENT
• Type of Device: TRACHEOBRONCHIAL STENT
• 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: david lockridge ; 1600 merit parkway; south jordan, UT 84095 ; 8012084551
• MDR Report Key: 9469404
• MDR Text Key: 185591240
• Report Number: 3010665433-2019-00084
• Device Sequence Number: 1
• Product Code: JCT
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 90129-201/JPC
• Device Lot Number: E1403811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• 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): Hospitalization; Required Intervention