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Patient Safety and Quality Improvement

(182) Eustachian Tube Balloon Dilation: An Analysis of the MAUDE Database

Monday, October 2, 2023
2:45 PM - 3:45 PM East Coast USA Time
Has Audio

    Presenting Author(s)

  • TM

    Tyler B. Merrill, MD

    Fellow
    Cleveland Clinic Foundation
    Cleveland, Ohio, United States

    • Co-Author(s)

  • Vijay A. Patel, MD

    Associate Physician
    University of California San Diego
    San Diego, CA, United States

  • CP

    Christopher D. Pool, MD

    Associate
    ENT and Allergy Specialists
    Phoenixville, Pennsylvania, United States

  • JD

    John L. Dornhoffer, MD

    Professor & Chair
    University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States

    • Senior Author(s)

  • RS

    Robert A. Saadi, MD

    Resident Physician
    University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States

Disclosure(s):
Tyler B. Merrill, MD: No relevant relationships to disclose.
Vijay A. Patel, MD: No relevant relationships to disclose.
Christopher D. Pool, MD: No relevant relationships to disclose.
John L. Dornhoffer, MD: No relevant relationships to disclose.
Robert A. Saadi, MD: No relevant relationships to disclose.


Introduction: Eustachian tube balloon dilation (ETBD) has been FDA approved for refractory eustachian tube dysfunction since 2016. While ETBD is generally seen as safe, the complication profile has not been well defined. The objective of this study was to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database to better assess adverse events (AE) related to ETBD.

Methods: The FDA MAUDE database was queried for all medical device reports (MDR) related to ETBD devices from January 2012 to November 2022. 88 MDRs were identified using search terms “eustachian tube” and “eustachian tube balloon dilation”, 16 of which met inclusion criteria. All product manufacturers were included in the final analysis. Reports were individually tabulated and events were categorized with special attention to AEs.

Results: During the study time period, 16 MDRs met inclusion criteria. 3 MDRs were classified as device related (18.8%), none of which resulted in an AE. 13 MDRs (81.3%) were patient related, all of which were classified as AEs. The most common AE was postoperative subcutaneous emphysema (46.2%)., All patients with subcutaneous emphysema had some involvement of either the face or neck or both. More concerningly, three patients suffered chest involvement. Of the six patients with subcutaneous emphysema, there was a wide variety in severity, with two patients managed conservatively on an outpatient basis, three requiring admission to a general hospital bed, and one patient requiring admission to the ICU and chest tube placement. The most severe AE was postoperative stroke secondary to carotid artery dissection requiring carotid artery stent placement.

Conclusions: Though ETBD is generally seen as a safe procedure, there have been several concerning AEs reported to date. An increased awareness of ETBD complications can provide better patient education and counseling during the informed consent process and aid surgeons in clinical decision making. Future studies with standardized reporting protocols are warranted to create a central registry for ETBD to further investigate root causes of associated complications.