Eustachian Tube Balloon Dilation: A Comprehensive Analysis of Adverse Events

Area of Science:

• Otolaryngology
• Medical Device Safety
• Health Informatics

Background:

• Eustachian tube balloon dilation (ETBD) received FDA approval in 2016 for refractory Eustachian tube dysfunction.
• While generally considered safe, the complication profile of ETBD requires further definition.

Purpose of the Study:

• To analyze adverse events (AE) associated with ETBD using the FDA MAUDE database.
• To better understand the safety profile and identify potential risks of ETBD.

Main Methods:

• A retrospective analysis of the FDA MAUDE database was conducted.
• Medical device reports (MDR) related to ETBD from January 2012 to November 2022 were queried.
• 16 unique MDRs met inclusion criteria for analysis.

Main Results:

• Most reported events (81.3%) were patient-related AEs, while 18.8% were device-related with no AEs.
• The most frequent AE was postoperative subcutaneous emphysema (46.2%).
• A rare but severe AE included postoperative stroke secondary to carotid artery dissection (6.3%).

Conclusions:

• ETBD is associated with concerning adverse events, including subcutaneous emphysema and stroke.
• Increased awareness of ETBD complications is crucial for informed patient consent and surgical decision-making.
• Standardized reporting and a central registry for ETBD are recommended for future studies.