Adverse events and modes of failure related to the Impella percutaneous left ventricular assist devices: a retrospective analysis of the MAUDE database

Percutaneous left ventricular assist devices (pLVAD) are indicated to provide short-term mechanical circulatory support in patients with cardiogenic shock, acute myocardial infarction (AMI) with cardiogenic shock, and for high-risk percutaneous coronary intervention (HRPCI)1. The Impella® device (Abiomed Inc., Danvers, MA, USA) is a non-pulsatile microaxial flow pump that continuously propels blood from the left ventricle (LV) to the ascending aorta. The Impella system is placed retrogradely across the aortic valve under fluoroscopic guidance, with its inflow in the LV and outflow in the ascending aorta. The Impella platform consists of several different models that vary in calibre, insertion technique, and maximum haemodynamic support capabilities. There are limited published post-approval surveillance data on the most commonly reported complications and failure modes associated with the Impella devices. We analysed the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to report these endpoints. © Europa Digital & Publishing 2019. All rights reserved.