Characteristic adverse events with the Arrow® AC3™ Optimus™ intra-aortic balloon pump (IABP): An analysis of the U.S. Food and Drug Administration MAUDE database from 2017 to 2025.

BACKGROUND

The Arrow® AC3™ Optimus™ Intra-Aortic Balloon Pump (IABP) is widely used for hemodynamic support in critically ill patients. Post-marketing surveillance data are essential to assess real-world safety and performance.

METHODS

We conducted a systematic analysis of medical device reports related to the AC3™ Optimus™ IABP submitted to the FDA Manufacturer and User Facility Device Experience (MAUDE) database between 2017 and 2025. Events were categorized into types of adverse events, device problems, and patient problems. Frequencies and proportions were calculated.

RESULTS

A total of 920 adverse events were identified. The majority were malfunctions (901, 97.9 %), followed by injuries (16, 1.7 %) and deaths (3, 0.3 %). Two of the reported deaths were reviewed in detail but were not clearly attributable to the device. Device problems (n = 1054) were most commonly related to the alarm system (146, 13.9 %), battery (126, 12.0 %), and gas/air leaks (101, 9.6 %). Other frequent issues included power problems (61, 5.8 %), connection problems (70, 6.6 %), and mechanical problems (53, 5.0 %). Patient problems were reported in 12 cases, with hypotension (2, 16.7 %), arrhythmia (1, 8.3 %), cardiac arrest (1, 8.3 %), hemorrhage (1, 8.3 %), and death (1, 8.3 %) among the documented outcomes. The majority of excluded patient problem reports (911, 98.7 %) lacked clinical details or showed no symptoms.

CONCLUSIONS

Most reported adverse events with the AC3™ Optimus™ IABP involved device malfunctions rather than direct patient injury or death. The most frequent device-related issues involved the alarm system, battery function, and gas/air leaks. While direct causality between device use and patient deaths was not established, vigilance in monitoring, device maintenance, and user training remains crucial to minimize risk.