Philipson DJ, Cohen DJ, Fonarow GC, et al. - In high risk percutaneous coronary intervention or cardiogenic shock, Impella devices are increasingly used for hemodynamic support despite no available randomized clinical trial data indicating clinical benefit and newer observational data suggesting harm. Researchers here conducted a retrospective analysis with the aim to ascertain the most common adverse events linked with Impella usage reported annually to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. In addition, they determined via the National Inpatient Sample (NIS) database the number of percutaneous ventricular assist devices (pVAD) used and linked with inpatient mortality since introduction of the Impella. From 2008 to 2019, 885 complete reports submitted to the MAUDE database related to Impella usage were identified; among these reports, 1,206 complications were coded. They observed the occurrence of 88.2% of reports between 2016 and 2019. Bleeding (32.8%), device deployment or retrieval issues (18.2%), vascular complications (15.8%), and death (12.4%) were the most common adverse events reported among patients, and 7.9% of all complications were attributable to operator decision-making or technique. Per findings, there is a substantial increase in Impella use over the last decade, however, it remained linked with high inpatient mortality and serious complications.