Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation

Abstract

Objective: Eustachian tube balloon dilation is a minimally invasive technique used to improve persistent Eustachian tube dysfunction. Currently, the US Food and Drug Administration (FDA) has approved the use of balloon dilation devices produced by three manufacturers, but little is known about associated adverse events and subsequent management.

Study design: Case series.

Setting: FDA Manufacturer and User Facility Device Experience (MAUDE) database.

Methods: Reports submitted to the FDA using the MAUDE database searched from January 2000 to July 2022 were analyzed for adverse events and management.

Results: A total of 13 adverse events were found in the database. Subcutaneous emphysema (n = 8) was the most common event. Other less frequent events included patulous Eustachian tube (n = 2), vascular dissection (n = 1), nasopharyngeal mucocele (n = 1), and tinnitus (n = 1). A majority of patients who experienced subcutaneous emphysema received antibiotics (n = 5) and were admitted to the hospital (n = 4). The patient with a carotid dissection 7 days postprocedure presented with a stroke and fully recovered after stent placement. There was limited preprocedure information in the MAUDE database. There were 2 patients who did not fully recover after a complication. Three patients underwent corrective surgical interventions. No one company had more associated adverse events reported.

Conclusion: Subcutaneous emphysema is the most common adverse event after Eustachian tube dilation. Further studies exploring potential balloon dilation adverse events to allow for better patient counseling are warranted.

Keywords: Eustachian tube dysfunction; Manufacturer and User Facility Device Experience; balloon dilation; subcutaneous emphysema.