[Risk Analysis of Adverse Events Associated with Implantable Left Ventricular Assist Devices].

Abstract

Objective: Based on multi-source monitoring data from both domestic and international sources, this study systematically analyzes the adverse events and recall characteristics associated with implantable left ventricular assist devices (LVADs) to provide a reference for clinical safety and regulatory optimization.

Methods: The data were sourced from two fatality reports submitted in Zhejiang Province, registration and recall information from the National Medical Products Administration (2 cases), and the U.S. Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) database (36,581 reports) and recall database (23 cases). A strategy combining descriptive statistics, root cause analysis (RCA), the Delphi method, and a risk matrix was employed.

Results: There were a total of 18,772 post-market malfunction-related events involving LVAD products, primarily involving pump malfunction (14.25%), electrical issues (12.44%), flow path obstruction (12.10%), and alarm/control system issues (10.80%); There were a total of 29,509 reported cases of patient injury-related events, with deaths accounting for 29.77%, infections for 16.09%, organ failure/cerebrovascular accidents/strokes for 13.52%, bleeding for 9.77%, and thrombosis for 5.96%. Among the 25 recalls in China and the U.S., Class I recalls accounted for 52%. The root causes were primarily design defects and manufacturing process deviations, which together accounted for over 60%. One fatality in Zhejiang Province was related to an unexpected shutdown of the blood pump during a controller replacement; the risk matrix indicated that blood clots within the pump and flow path blockages, as well as pump malfunctions, were in the unacceptable zone.

Conclusion: As a Class Ⅲ high-risk implantable medical device that saves the lives of patients with end-stage heart failure, the real-world risks associated with LVADs primarily involve device malfunctions (pump malfunction, electrical issues, and flow path obstruction) and serious adverse events (death, infection, organ failure/cerebrovascular accident/stroke, bleeding, and thrombosis); recalls are often attributed to design and manufacturing defects. It is recommended that registrants strengthen lifecycle management and incorporate redundant designs, that healthcare institutions standardize the reporting of adverse events, and that regulatory authorities enhance targeted monitoring.