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 Epistaxis (4458)

Event Date 12/09/2023

Event Type  Injury  

Event Description

The patient received vivaer treatment of the inferior turbinates and swell bodies on (b)(6) 2023.Approximately 1 month post treatment ((b)(6) 2023) the patient experienced a severe nosebleed and went to the emergency room and had embolism of the spa done to stop the bleeding and spent 5 days in the hospital.The patient reported that they lost nearly 2 pints of blood and that she was recovering but in pain and their throat was irritated from the intubation tube.Approximately 1 week later, the patient experienced a second nosebleed and returned to the emergency room.A cerebral angiogram was performed, and the patient had embolization of the spa repeated to stop the bleeding.The patient is recovering.

Manufacturer Narrative

Nose bleeds are a known potential side effect related to the use of radiofrequency energy on tissue in the nose.This side effect is listed in the device labeling.

• 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 189969, sgp 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043
• MDR Report Key: 18490156
• MDR Text Key: 332603602
• Report Number: 3011625895-2024-00001
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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
• Date Manufacturer Received: 12/14/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female