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

Model Number FG722

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

Patient Problem Perforation (2001)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

Deterioration of mucosa probably exacerbated with use of topical nasal decongestant spray.Topical nasal decongestant sprays have been reported to cause mucosal perforation.

Event Description

On (b)(6) 2022, the patient was treated with the vivaer stylus only on the right side.The swell body, internal nasal valve and the inferior turbinate were treated.Patient had first follow up visit on (b)(6) 2022 and again on (b)(6) 2022.At both visits, the patient showed good mucosal healing.At third follow-up visit on (b)(6) 2022, muscosa was intact.Physician discussed septo-turb option with the patient because patient was still complaining of congestion.At 7-month follow-up on (b)(6) 2022, patient presented with crusting on septum and 1x1 cm2 mucosal perforation in area treated with vivaer stylus.Cartilage was intact.The patient reported using afrin off and on for past month.Physician plans to move forward with septoplasty procedure to address persistent congestion.Topical nasal decongestant sprays have been reported to cause mucosal perforation.The deterioration of the mucosa is probably related to the combination of the radiofrequency treatment of the tissue in the area followed by use of afrin.

• Brand Name: VIVAER STYLUS
• Type of Device: 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: 15307612
• MDR Text Key: 298758564
• Report Number: 3011625895-2022-00004
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08886479300160
• UDI-Public: 08886479300160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG722
• Device Catalogue Number: CAT723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Male