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

Model Number 00884450030776

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that the stent fractured approximately 45 days after implantation.The fracture required the removal of the stent.The patient is doing well; however, the disease is no longer being treated.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed.No stent fracture was seen as nitinol metal frame was intact, but holes were seen in the stent.Holes seemed to be present in areas with excessive tissue growth.Note: tissue growth is dependent on each individual patient and the stage/condition of their malignancy.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: AERO®
• Type of Device: 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: 17308145
• MDR Text Key: 319386728
• Report Number: 3010665433-2023-00056
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00884450030776
• UDI-Public: 00884450030776
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450030776
• Device Catalogue Number: 90129-215EU/C
• Device Lot Number: E2167099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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