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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.
Insights
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.
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.
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