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

Model Number	FG257
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Scar formation is a known potential adverse event and documented in the device labeling.
Event or Problem Description
Patient had a procedure to address nasal airway obstruction with vivaer arc stylus.The nasal valve area including the lateral nasal wall for both left and right nostrils were treated.During the 90 days post procedure follow up, a mass was noticed in the treated area on the right lateral wall of the nasal valve.No issues were reported regarding the treated area in the left nostril.Aerin medical was informed no medical intervention is required.Aerin medical continued to follow up with the clinic.However, nine (9) days later the clinic mentioned that a procedure would be scheduled to remove the mass.The mass was removed the following week and sent for pathology examination.The pathology results showed fibrotic soft tissue (scar tissue).The physician further confirmed that the patient is fine.There was no report of device malfunction by the clinic.

• Brand Name: VIVAER ARC STYLUS
• Common Device Name: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 232 e caribbean drive; sunnyvale CA 94089
• MDR Report Key: 11243343
• Report Number: 3011625895-2021-00001
• Device Sequence Number: 3966542
• Product Code: GEI
• UDI-Device Identifier: 08886479300146
• UDI-Public: 08886479300146
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

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: 03/01/2022
• Device Model Number: FG257
• Device Catalogue Number: CAT410
• Device Lot Number: 27503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Weight: 65