Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020.

Autor:	Shah VN; 12235University of Miami Miller School of Medicine, Miami, Florida., Pasick LJ; 12235University of Miami Miller School of Medicine, Miami, Florida., Benito DA; 43989George Washington University School of Medicine and Health Sciences, Washington, District Columbia., Ghiam MK; 12235University of Miami Miller School of Medicine, Miami, Florida., D'Aguillo C; 12235University of Miami Miller School of Medicine, Miami, Florida.
Jazyk:	angličtina
Zdroj:	American journal of rhinology & allergy [Am J Rhinol Allergy] 2022 Mar; Vol. 36 (2), pp. 185-190. Date of Electronic Publication: 2021 Aug 03.
DOI:	10.1177/19458924211035641
Abstrakt:	Background: Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Objective: To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Methods: The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents. Results: After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%). Conclusions: PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage.
Databáze:	MEDLINE
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