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

Model Number 00884450030691

Device Problems Fracture (1260); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  Injury  

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.

Event Description

The account alleges that post tracheobronchial stent placement, the tracheobronchial stent had fractured in vi-vo.The patient returned to the healthcare facility to undergo a stent removal procedure.The fractured stent was successfully removed by the physician and a new tracheobronchial stent was deployed without any additional consequences for the patient.

• 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: bryson heaton r.n. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 11158930
• MDR Text Key: 226551741
• Report Number: 3010665433-2021-00003
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00884450030691
• UDI-Public: 00884450030691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450030691
• Device Catalogue Number: 90129-207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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