P963Coronary orbital atherectomy manufacturers and user facility device experience (MAUDE) database: a 5-year analysis of real-world complications

Abstract

Abstract Background Coronary Orbital Atherectomy System was approved by the United States FDA (food and Drug Administration) on October 21st, 2013. The initial safety data were published in the ORBIT I trial. Purpose Evaluation of the reported real-life complications related to utilization of orbital coronary atherectomy system since its approval in the United States using the online FDA database. Methods The Manufacturer and User facility Device Experience (MAUDE) database was queried for all complication reports involving the orbital atherectomy (OA) “Diamondback 360 coronary orbital atherectomy system” from 1/1/2013 through 12/31/2018. All reports were searched for complications; mortality, perforation, dissections, device fragmentation, and the need for surgical intervention among reported procedures. Duplicate entries and data with no reporting on final procedure outcome were excluded. Results Over the allocated interval519 reports were identified. Seven reports were excluded (according to exclusion criteria). Over the period of slightly more than five years, coronary perforation was the most commonly reported complication mounting to 44.14% of all the reports (226 reports). Device fragmentation was reported in 18.94% of the reports (97 reports). Surgery was needed to retrieve device fragments in 13 cases (13.4% of all device fragmentation reports). Coronary dissection represented 16.21% of the reports (83 reports) and total surgical interventions were needed in 14.25% of the cases (73 reports). Finally, total reported deaths were 121 cases (23.63% of the total reports). Year 2013 2014 2015 2016 2017 2018 Number of reported complications 4 28 46 81 113 247 Percentage of reported complications Discussion The current analysis, representing data from real world reported complications to the FDA over a period of 5 years, shows that the most common reported complication during coronary orbital atherectomy was coronary perforations, followed by device breakings and fragmentation (which necessitated surgical intervention in almost 13.4% of those device fragmentation cases reported). It is hard to compare these data with published safety trials since the FDA database is involved in reporting complications and not total number of procedures. However the most striking complication involved device fragmentation, which was not seen or reported among the pivotal trials evaluating device safety. The current analysis may shed some light on a non reported complication among patients undergoing orbital atherectomy which might represent a gap between the device performance in real world as opposed to a well-designed study world.