MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING AERO.STENT; TRACHEOBRONCHIAL STENT

Model Number 00884450030738

Device Problem Unclear Information (4052)

Patient Problem Airway Obstruction (1699)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return 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.Should the device return at a later date, the investigation will be re-opened.

Event Description

A research paper identified a case report that alleges a tracheobronchial stent, implanted in (b)(6) 2018 within the patient's left main bronchus, had totally occluded with granulation tissue.The stent was removed, and the patient has undergone frequent ablation procedures.

• Brand Name: AERO.STENT
• Type of Device: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 10687300
• MDR Text Key: 211681778
• Report Number: 3010665433-2020-00040
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00884450030738
• UDI-Public: 00884450030738
• Combination Product (y/n): Y
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 00884450030738
• Device Catalogue Number: 90129-211/C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/15/2020
• 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