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Updated: Nov 9, 2025
08:26
Design of a Biocompatible Drug-Eluting Tracheal Stent in Mice with Laryngotracheal Stenosis
Published on: January 21, 2020
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Adverse Events Associated With Corticosteroid-Eluting Sinus Stents: A MAUDE Database Analysis
Vishal Narwani1, Sina J Torabi1, David A Kasle1
1Division of Otolaryngology, Department of Surgery, School of Medicine, Yale University, New Haven, Connecticut, USA.
Summary
Corticosteroid-eluting stents (CESs) pose risks, with postoperative infection and stent migration being the most common adverse events. Awareness of these complications is crucial for informed patient consent and surgical decision-making.
Area of Science:
- Otolaryngology
- Medical Device Safety
- Surgical Complications
Background:
- Corticosteroid-eluting stents (CESs) are utilized post-endoscopic sinus surgery to minimize revision rates.
- However, the use of CESs is associated with potential adverse events that require careful consideration.
Purpose of the Study:
- To identify and describe the adverse events associated with corticosteroid-eluting stents (CESs).
Main Methods:
- A retrospective cross-sectional study analyzed data from the US Food and Drug Administration's MAUDE database (2011-2020).
- Adverse events related to FDA-approved CESs, specifically the Propel family and Sinuva stents, were queried.
Main Results:
- A total of 28 adverse events were reported, exclusively involving the Propel stent family.
- Postoperative infection (39%), including fungal infections, and stent migration (21%) were the most frequent complications.
- Twenty-nine percent of patients required reintervention for stent removal.
Conclusions:
- Postoperative infection and stent migration are the primary adverse events linked to CESs.
- Enhanced awareness of these risks can improve patient counseling and surgical planning.
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