[Risk Analysis of Adverse Events Associated with Implantable Left Ventricular Assist Devices].
PMID: 42865058 ·
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Abstract
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. 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
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