Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020.
Am J Rhinol Allergy
; 36(2): 185-190, 2022 Mar.
Article
em En
| MEDLINE
| ID: mdl-34342518
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
/
Stents Farmacológicos
Tipo de estudo:
Risk_factors_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article