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

Model Number FG257

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

Scar formation is a known potential adverse event and documented in the device labeling.

Event 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
• Type of Device: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 232 e caribbean drive; sunnyvale CA 94089
• Manufacturer (Section G): AERIN MEDICAL SINGAPORE PTE. LTD.; 60 albert street #16-01; singapore 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 232 e caribbean drive; sunnyvale, CA 94089 ; 5122219956
• MDR Report Key: 11243343
• MDR Text Key: 229105454
• Report Number: 3011625895-2021-00001
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08886479300146
• UDI-Public: 08886479300146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 65