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

Catalog Number 90129-201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Airway Obstruction (1699)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The physician alleges that a tracheobronchial stent was easily crushed by external forces within the patient's trachea.The stent was originally placed for extrinsic compression.The stent was deployed under direct vision without any complications to the patient.The physician states that the stent was fully dilated, and no stent deformation was identified post deployment.The patient presented three days later with dyspnea due to the tracheobronchial "stent crush".The physician states that "stent crush" is not life threatening, but it was necessary for the physician to remove the tracheobronchial stent and deployed a new one.

• 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: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 7605937
• MDR Text Key: 111200039
• Report Number: 3010665433-2018-00040
• 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
• Report Date: 05/24/2018

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: Physician
• Device Catalogue Number: 90129-201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention