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

Abstract

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.