Characteristic adverse events with intra-aortic balloon pumps: An analysis of the U.S. Food and Drug Administration MAUDE database from 2016 to 2021
Abstract
Introduction
The United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) dataset represents a unique source for post-market surveillance data on adverse events (AE). An analysis of AE with percutaneous mechanical circulatory support (pMCS) devices has previously been reported specifically for microaxial flow pumps. The characteristic AE for the intra-aortic balloon pump (IABP) have not been similarly analyzed or reported.