Adverse Events Associated with Balloon Sinuplasty: A MAUDE Database Analysis

Abstract

Objective Balloon sinuplasty utilization has increased significantly since its introduction over a decade ago. However, the most common associated complications are still unknown. The objective of this study was to analyze adverse events related to balloon sinuplasty. Study Design Retrospective cross-sectional analysis. Setting Food and Drug Administration’s MAUDE database (Manufacturer and User Facility Device Experience; 2008-2018). Subjects and Methods The MAUDE database was searched for all reports on adverse events involving balloon sinuplasty devices from the 3 leading manufacturers: Acclarent, Entellus, and Medtronic. Reported events were reviewed and categorized. Results During the study period, there were 211 adverse events from 208 reports divided into the following categories: patient related (n = 102, 48.3%), device related (n = 101, 47.9%), and packaging related (n = 8, 3.8%). Four periprocedural deaths were reported but were not clearly associated with technical complications. The most common device-related complications were guide catheter malfunction (39.6%), balloon malfunction (38.6%), and imprecise navigation (17.8%). The most common patient-related complications were cerebrospinal fluid leak (36.3%), eye swelling (29.4%), and epistaxis (11.8%). A lateral canthotomy was performed in 30.0% of eye-swelling complications. Sixty percent of eye complications occurred during balloon dilation of the maxillary sinus. The years 2014 (n = 48) and 2012 (n = 32) had the highest number of adverse events reported as compared with all other years. Conclusion The most common adverse events associated with balloon sinuplasty include balloon malfunction, guide catheter malfunction, cerebrospinal fluid leak, and significant eye swelling. Health care providers should discuss these possible complications when consenting patients for balloon sinuplasty.

Tension Pneumocephalus Following Balloon Sinuplasty

“…1 As the number of BSD cases has increased, so have the number of BSD-related complications. 4 Initial studies reported that complication rates with balloon sinuplasty were as low as 0.01%. 10 Although rare, these complications are not insignificant.…”

Prolonged Implantation of Sinus Devices and Implications for Chronic Rhinosinusitis: A Case Report and Review of the Literature

“…After these cases, we queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for reports regarding Relieva Stratus™ MicroFlow Frontal Sinus Spacers, the brand of sinus implant removed from both patients. The MAUDE database was developed by the FDA to compile all adverse events reported for a particular product, and both manufactures, and providers are required to submit reports whenever an adverse event occurs [13]. We identified eight adverse events attributed to the Relieva Stratus™ MicroFlow Frontal Sinus Spacers, two of which were cases of a retained spacer in the frontal sinus [14].…”

An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

“…This study provides a comprehensive evaluation of use error adverse events decomposed by several key event attributes to address the gaps in the availability of industrywide statistics. Past work has used MAUDE data to examine adverse events associated with specific devices (Hill et al, 2017;Hur et al, 2019;Krouwer, 2018;Shlofmitz et al, 2019) and specific malfunctions (Kohani & Pecht, 2018). The work presented in this paper sought to evaluate adverse events across all devices, specifically for use error.…”