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.

Material and methods: All events in the MAUDE dataset between January 1, 2016 and December 31, 2021 were reviewed involving the Linear, Mega and Sensation devices (Datascope/Getinge, Wayne New Jersey). Data was analyzed by two authors and categorized based on AE type, date, event type and device-related or patient-related AE.

Results: A total of 2795 AE were reported over five years. Device malfunction (91.4 %) was the most frequent classification followed by death (5.6 %) and injury (3.0 %). Catheter deformation/fracture/leak accounted for 37.9 % of total AEs. The most common patient event categorization was asymptomatic (90.8 %). Vessel damage/hemorrhage occurred in 1.4 % of reports. Death occurred in 5.6 % of reports and was associated with cardiac arrest in 110 of 156 events. Thrombus formation was described in 1.1 % of AEs. Device optic AE were common and unique to Sensation catheters. Calibration errors were also more common with Sensation (4.6 % versus 1.3 %) compared to other models.

Conclusions: Publicly reported AE with IABPs are predominantly device malfunctions without clinical sequelae. Injury, vascular damage, bleeding and thrombosis AEs are not frequent amongst reported AEs. Emphasis should be placed on understanding mechanisms of device malfunction in order to improve both reliability and user experience.

Keywords: Adverse events; Intra-aortic balloon pump; MAUDE.