Abstract 11755: Adverse Events of Third Generation Left Ventricular Assist Devices: Insights From the Manufacturer and User Facility Device Experience Database

Abstract

Background: Left ventricular assist devices (LVAD) are used frequently to treat end-stage heart failure. The HeartMate 3 (HM-3), the newest LVAD, has limited data on complications. We analyzed the post-marketing surveillance data from the Manufacturer and User Facility Device Experience (MAUDE) database to evaluate complications from the HM-3. Methods: We queried the MAUDE database for device event reports of the HM-3 LVAD from 1/1/2017 to 12/31/2019. We screened event reports for completeness, stratified complications into the device and patient effects, and used descriptive analyses on the compiled reported complications. Results: In this time period, 3,867 device reports met the search criteria, of which 961 identifiable device-specific complications were reported. The most common device events reported were infusion flow disruptions (21.0%), halted pump (9.2%), and material deformation (8.4%). Additionally, 5,676 events affecting patients were also reported in this period. Not counting death, blood loss (21.8%), infection (17.8%), and thrombus (3.3%) were the most commonly reported clinical events. Lastly, 535 deaths were reported, stemming from cerebral vascular accidents (9.7%) and hemorrhage (6.7%). Device events, patient events, with device and patient events associated with death are represented in Figure 1 . Conclusion: Findings from the MAUDE database provide insight into complications and risks of the HM-3 LVAD. Addressing the complications and understanding the risk may improve clinical outcomes for patients with refractory heart failure. Figures 1A, 1B, 1C, 1D