Adverse Events Associated With Corticosteroid-Eluting Sinus Stents: A MAUDE Database Analysis

• Published in: Otolaryngology-head and neck surgery Vol. 166; no. 1; pp. 179 - 182
• Main Authors: Narwani, Vishal, Torabi, Sina J., Kasle, David A., Patel, Rahul A., Lerner, Michael Z., Manes, R. Peter
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01-01-2022
• Subjects: Anti-Inflammatory Agents - administration & dosage; corticosteroid‐eluting stent; Cross-Sectional Studies; Databases, Factual; Drug-Eluting Stents - adverse effects; Endoscopy - adverse effects; FDA; Humans; MAUDE; mometasone; Mometasone Furoate - administration & dosage; otolaryngology; Paranasal Sinus Diseases - surgery; Postoperative Complications - epidemiology; Propel; Retrospective Studies; United States; United States; corticosteroid-eluting stent; MAUDE; FDA; otolaryngology; Propel; mometasone
• ISSN: 0194-5998; 1097-6817
• DOI: 10.1177/01945998211006930

Objective
Corticosteroid-eluting stents (CESs) are increasingly used after endoscopic sinus surgery to reduce the need for revision surgery, but their use is not without risks. The objective of this study is to describe adverse events related to CESs.
Study Design
Retrospective cross-sectional study.
Setting
The US Food and Drug Administration’s MAUDE database (2011-2020; Manufacturer and User Facility Device Experience).
Methods
The MAUDE database was queried for reports of adverse events involving the use of CESs approved by the Food and Drug Administration, including Propel, Propel Mini, Propel Contour, and Sinuva (Intersect ENT).
Results
There were 28 reported adverse events in total, with all events being related to the Propel family of stents and none related to Sinuva stents. Overall, 22 were categorized as patient-related adverse events and 6 as device-related events. The most common adverse event was related to postoperative infection, accounting for 39% (n = 11) of all complications. Four of these patients developed periorbital cellulitis, and 5 developed a fungal infection. The second-most common adverse event was migration of the stent, representing 21% of all complications (n = 6). Overall, 8 patients (29%) in our cohort required reintervention in the operating room, with subsequent removal of the CES.
Conclusion
The most commonly reported adverse events were postoperative infection, including multiple cases of fungal infection, followed by migration of the stent. An increased awareness of the complications associated with CESs can be used to better inform patients during the consenting process as well as surgeons in their surgical decision making.