E-060 Analysis of reported adverse events of flow-diverter stents for intracranial aneurysms using the FDA MAUDE database

• Published in: Journal of neurointerventional surgery Vol. 14; no. Suppl 1; pp. A107 - A108
• Main Authors: Porwal, M, SenthilKumar, G, Kumar, D, Sinson, G
• Format: Journal Article
• Language: English
• Published: BMA House, Tavistock Square, London, WC1H 9JR BMJ Publishing Group Ltd 23.07.2022; BMJ Publishing Group LTD
• Subjects: Aneurysms; Deformation; Medical equipment; SNIS 19th annual meeting electronic poster abstracts; Surveillance
• ISSN: 1759-8478; 1759-8486
• DOI: 10.1136/neurintsurg-2022-SNIS.171

Introduction/PurposeFlow-diverter stents have recently emerged as a safe and effective alternative to surgical clipping for large and wide-neck intracranial aneurysms. However, after its approval for use in the United States in 2011, post-market surveillance of adverse events is limited. This study aims to address this critical knowledge gap by characterizing reported adverse events and device problems in patients treated with flow-diverter stents.Materials and MethodsUsing post-market surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE), patient and device related (PR;DR) reports from January 2012-December 2021 were extracted, compiled, and analyzed with R-Studio version 2021.09.2. PR and DR reports with insufficient information were excluded.ResultsDuring the study period, a total of 5537 medical device reports were extracted. After removing reports with insufficient information and no adverse events or device problems, 2203 PR and 4017 DR events were recorded. The most frequently reported PR adverse event categories were cerebrovascular (60%), death (11%), and neurological (8%). The most frequent PR adverse event reports were death (11%), thrombosis/thrombus (9%) cerebral infarction (8%), stroke/cerebrovascular accident (6%), decreased therapeutic response (6%), intracranial hemorrhage (5%), aneurysm (4%), occlusion (4%), headache (4%), neurological deficit/dysfunction (3%). The most frequent DR reports were activation/positioning/separation problems (52%), break (9%), device operates differently than expected (4%), difficult to open or close (4%), material deformation (3%), migration or expulsion of device (3%), detachment of device or device component (2%). Yearly PR reports increased from 114 in 2012 to 292 in 2021. Yearly DR reports increased from 270 in 2012 to 641 in 2021.Abstract E-060 Figure 1ConclusionsPost-market surveillance is an important to guide patient counselling and identify adverse events and device problems that were not identified in initial trials. Although there are inherent limitations to the MAUDE database, our results highlight some important PR and DR complications that can help optimize patient counseling and management.Disclosures M. Porwal: None. G. SenthilKumar: None. D. Kumar: None. G. Sinson: None.