MAUDE Adverse Event Report: VISIONAIR SOLUTIONS VISIONAIR 3D STENT; TRACHEAL/BRONCHIAL STENT

Model Number	0010-0126
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Upper Respiratory Tract Irritation (4872)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient received a visionair 3d stent and developed an irritation in the airway that was explanted.Device not returned.Device history records were reviewed.There were no reported anomalies with the materials, manufacturing, cleaning, or packaging process.Ncms were reviewed.There were no reported issues with materials, manufacturing, cleaning or packaging.Complaints were reviewed.There are no other similar adverse events reported for the visionair 3d stent.Irritation of the airway and/or inflammatory reponse are known risks and listed in visionair instructions for use.Based on the provided information, it is not possible to attribute the reported adverse event to a device failure or device-related issue.
Event or Problem Description
Patient had a reported irritation to airway after implantation of visionair 3d stent.

• Brand Name: VISIONAIR 3D STENT
• Common Device Name: TRACHEAL/BRONCHIAL STENT
• Manufacturer (Section D): VISIONAIR SOLUTIONS; 1800 triplett blvd; akron OH 44306
• Manufacturer Contact: garrett spurgeon ; 1800 triplett blvd; akron, OH 44306 ; 3307337600
• MDR Report Key: 24821147
• Report Number: 3010197296-2026-00001
• Device Sequence Number: 20321563
• Product Code: NWA
• UDI-Device Identifier: 00860011822608
• UDI-Public: 00860011822608
• Combination Product (Y/N): N
• PMA/510(K) Number: K213969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 04/07/2026
• Device Model Number: 0010-0126
• Device Lot Number: Y.2512034.B.01C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male