Abstract 13319: The Barostim Baroreflex Activation Therapy System: Safety Insights From FDA MAUDE Database

Abstract

Introduction: BAROSTIM NEO® is a Baroreflex activation therapy (BAT) system which has been approved recently by FDA for patients with refractory heart failure. Post market experience of BAT related complications and performance issues have not been reported. Objective: To analyze the post-approval device failures and patient related adverse events (AE) associated with Barostim NEO® system using Manufacturer and User Facility Device Experience (MAUDE) database. Methods: A MAUDE database search was conducted on December 7, 2022, for reports received between Jan 1, 2019, to November 30, 2022. Manual search of the MAUDE database conducted using the term “Barostim” in the brand name section. The AE were adjudicated to various categories based on the review of the event description for each medical device report (MDR). Results: A total of 22 events were reported which included MDRs reported by physicians or manufacturer or both. Device related malfunction was reported in 45.5% (n=10) whereas patient related AE reported in 77.3% (n=17) cases. Of total device related AE, material split, cut or torn was most commonly reported problem (32%, n=7), followed by high impedance (13.6%, n=3) and low impedance (9.1%, n=2). Of the patient related AE, 32% (n=7) were related to clinical or subclinical infection, 18.2% (n=4) hematoma, 13.6% (n=3) heart failure or myocardial injury, 9.1% (n=2) stroke/CVA, 9.1% and 9.1% (n=2) twiddler’s syndrome. No carotid artery or jugular injury and procedure related death reported in the study period. The report is limited by the lack of information on the total number of BAT devices implanted across the country. Conclusions: This study provides a wide range of device malfunction and patient related post-approval adverse events for Barostim device which have not been reported in any clinical trial/study before. The reported complications seem to be in line with other cardiac implantable electronic devices and no BAT specific complications were noted.