MAUDE Adverse Event Report: AERIN MEDICAL INC. VIVAER STYLUS; RADIOFREQUENCY PROBE

Model Number	FG722
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Cartilage damage (4833)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented with external nasal valve collapse and lower lateral cartilage stenosis.The physician treated the lower lateral cartilage and alar cartilage with the vivaer stylus and reported overlapping some treatments.The patient returned for follow up after a period of several months with absorption of a portion of the lower lateral cartilage and worsening of the external nasal valve collapse.Approximately 14 months later, a revision surgery was performed, open valve nasal reconstruction.It was also reported that the patient had two previous nasal surgeries including a rhinoplasty.Based on these circumstances, intentional use error caused and contributed to the reported event.Additional information from the physician states they are aware of indications for use.Aerin medical will continue to monitor and trend for reports of this nature.

• Brand Name: VIVAER STYLUS
• Common Device Name: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 2565 leghorn st.; mountain view CA 94043
• Manufacturer (Section G): AERIN MEDICAL SINGAPORE PTE. LTD.; 60 albert street #16-01; singapore 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043 ; 5122219956
• MDR Report Key: 21532491
• Report Number: 3011625895-2025-00002
• Device Sequence Number: 18107019
• Product Code: GEI
• UDI-Device Identifier: 08886479300160
• UDI-Public: 08886479300160
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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: FG722
• Device Catalogue Number: CAT723
• 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: 02/04/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown