Trends and incidence of reported events associated with ureteral stents: An analysis of the food and drug administration’s manufacturer and user facility device experience database

You have accessJournal of UrologyCME1 Apr 2023MP35-11 TRENDS AND INCIDENCE OF REPORTED EVENTS ASSOCIATED WITH URETERAL STENTS: AN ANALYSIS OF THE FOOD AND DRUG ADMINISTRATION'S MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE Antonio Nacchia, Carmen Gravina, Luca Sarcinelli, Alessio Guidotti, Filippo Zammitti, Daniele Fiasconaro, Nicola Ghezzo, Antonio Cicione, Antonio Franco, Elisa Mancini, Giorgio Guarnotta, Riccardo Lombardo, Giorgia Tema, Yazan Al Sahli, Antonio Luigi Pastore, Antonio Carbone, Alessandro Sciarra, Francesco Del Giudice, Stefano Salciccia, Costantino Leonardo, Giorgio Franco, Andrea Tubaro, and Cosimo De Nunzio Antonio NacchiaAntonio Nacchia More articles by this author , Carmen GravinaCarmen Gravina More articles by this author , Luca SarcinelliLuca Sarcinelli More articles by this author , Alessio GuidottiAlessio Guidotti More articles by this author , Filippo ZammittiFilippo Zammitti More articles by this author , Daniele FiasconaroDaniele Fiasconaro More articles by this author , Nicola GhezzoNicola Ghezzo More articles by this author , Antonio CicioneAntonio Cicione More articles by this author , Antonio FrancoAntonio Franco More articles by this author , Elisa ManciniElisa Mancini More articles by this author , Giorgio GuarnottaGiorgio Guarnotta More articles by this author , Riccardo LombardoRiccardo Lombardo More articles by this author , Giorgia TemaGiorgia Tema More articles by this author , Yazan Al SahliYazan Al Sahli More articles by this author , Antonio Luigi PastoreAntonio Luigi Pastore More articles by this author , Antonio CarboneAntonio Carbone More articles by this author , Alessandro SciarraAlessandro Sciarra More articles by this author , Francesco Del GiudiceFrancesco Del Giudice More articles by this author , Stefano SalcicciaStefano Salciccia More articles by this author , Costantino LeonardoCostantino Leonardo More articles by this author , Giorgio FrancoGiorgio Franco More articles by this author , Andrea TubaroAndrea Tubaro More articles by this author , and Cosimo De NunzioCosimo De Nunzio More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003269.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: The MAUDE database was analyzed for all MDRs relating to each FDA-approved ureteral stents for the last ten years. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). No further data was available in the database. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data. RESULTS: Overall, 2652 reports were retrieved in 10 years and a progressive rise in reported events was recorded (Figure 1). Overall, 831/2652 (31%) were reported as injury while 1810/2652 (68%) as malfunction of the ureteral stent and 4 events of death. The most frequently reported AEs were stent break (627/2652:23%); material problems (384/2652: 14%); calcification (222/2652:8%); difficult to insert, advance or remove the device (155/2652: 6%). In terms of manufacturer: 875/2652 (33%) were Resonance stents, 871/2652 (33%) were Cook, 690/2652 (26%) were Bard and 130/2652 (5%) were filiform double pigtail ureteral stent set. Bard stents were associated with most material problems reports (19%), Resonance stents were associated with most difficulty to insert advance or remove the device (9%) and calcification (15%) while filiform double pigtail ureteral stent set were associated with most break reports (56%) when compare to the other stents (PRR>1, p<0,05) (Figure 1). CONCLUSIONS: Standing to MAUDE database the most frequent complications related to ureteral stents are break, material problems, calcification and difficulty to insert, advance or remove the device. As well Resonance ureteral stents seem to be associated with a higher risk of device problems. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e473 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Antonio Nacchia More articles by this author Carmen Gravina More articles by this author Luca Sarcinelli More articles by this author Alessio Guidotti More articles by this author Filippo Zammitti More articles by this author Daniele Fiasconaro More articles by this author Nicola Ghezzo More articles by this author Antonio Cicione More articles by this author Antonio Franco More articles by this author Elisa Mancini More articles by this author Giorgio Guarnotta More articles by this author Riccardo Lombardo More articles by this author Giorgia Tema More articles by this author Yazan Al Sahli More articles by this author Antonio Luigi Pastore More articles by this author Antonio Carbone More articles by this author Alessandro Sciarra More articles by this author Francesco Del Giudice More articles by this author Stefano Salciccia More articles by this author Costantino Leonardo More articles by this author Giorgio Franco More articles by this author Andrea Tubaro More articles by this author Cosimo De Nunzio More articles by this author Expand All Advertisement PDF downloadLoading ...