MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. AERO®; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	00884450030844
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that a patient had lost consciousness while lying flat, during a routine medical examination.The patient was transferred to the hospital.Ct findings showed 3 cm tumor occluding almost of the patient's airway.A debulking procedure was achieved, and endotracheal intubation was completed.The pathology findings showed the patients tumor was benign.An aero stent [2 x 4 cm] was placed within patient's trachea to cover the tumor.After the placement of the stent, extubating was achieved, and the patient was discharged to home.Due to the development of granulation tissue around the stent, interventions were performed 6, 10, 16 and 19 months after the original deployment of the stent.However, granulation tissue gradually got harder, and the treatment was more difficult for the patient.In addition, stent migration was also suspected.Surgical stent removal was then planned and was conducted with a rigid endoscope.The (metal) framework within the stent could be grasped with alligator forceps.It was torn off into small pieces.After repeating the attempt for a few times, the cranial end of the stent was then grasped, and the stent was successfully explanted by rolling it up and pulling it into the rigid endoscope.Four months after surgical removal, airway stenosis has not been found within the patient.
Additional Manufacturer Narrative
The suspect medical device was not returned 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 reopened.

• Brand Name: AERO®
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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 ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15721806
• Report Number: 3010665433-2022-00120
• Device Sequence Number: 2995827
• Product Code: JCT
• UDI-Device Identifier: 00884450030844
• UDI-Public: 00884450030844
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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 Model Number: 00884450030844
• Device Catalogue Number: 90129-216
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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