MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING AERO®.STENT, TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Catalog Number	90129-211/C
Medical Device Problem Codes	Partial Blockage (1065); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that on (b)(6) 2021 a tracheobronchial stent was implanted in respiratory surgery.On (b)(6) 2021, the patient was discharged from the hospital in good postoperative condition.On (b)(6) 2021, the patient had trouble breathing.On (b)(6) 2021, a ct scan was performed during follow up examination.It was noted that sputum had accumulated within the stent.On (b)(6) 2021, the patient was admitted and underwent an interventional procedure to remove the sputum endoscopically with a flexible bronchoscope.Chemotherapy and the other treatments were performed on the patient.On (b)(6) 2021, bronchoscopy was re-performed, and it was confirmed that the accumulation had improved.On (b)(6) 2021, the patient was discharged.On (b)(6) 2021 the patient expired due to the progression of the patient's disease.
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be re-opened.

• Brand Name: AERO®.STENT, TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 13181571
• Report Number: 3010665433-2022-00004
• Device Sequence Number: 4404486
• Product Code: JCT
• UDI-Device Identifier: 00884450030738
• UDI-Public: 884450030738
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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 Expiration Date: 09/27/2025
• Device Catalogue Number: 90129-211/C
• Device Lot Number: E1958063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown