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

Catalog Number	AERO1010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The account alleges that on (b)(6) 2019, post left upper lobe tracheobronchial stent placement procedure, the patient was doing fine.On (b)(6) 2019, the patient's oxygen saturations dropped significantly.The patient was transferred to icu and administered oxygen via high flow nasal cannula consequently correcting the patient's low o2 saturation event.The physician was suspicious of a possible tracheal bronchial airway obstruction, so the patient was transferred to a surgical procedure room for verification.The stent was obstructed with mucous secretions, so the tracheobronchial stent was removed by the physician.The stent removal procedure was considered unremarkable by the physician.The patient was transferred back to icu still intubated for recovery.

• Brand Name: AERO TRACHEOBRONCHIAL STENT
• Common Device Name: THRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 9151977
• Report Number: 3010665433-2019-00063
• Device Sequence Number: 2941823
• Product Code: JCT
• UDI-Device Identifier: 00884450307922
• UDI-Public: 00884450307922
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: AERO1010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention