Analysis of Adverse Events and Influencing Factors of Coronary Artery Stents Based on FDA MAUDE Database
Objective:To analyze the occurrence of adverse events and related problems of coronary artery stents and provide recommendations for their safety.Methods:Reports of 5060 cases of coronary stent adverse events were collected from the MAUDE database of the US Food and Drug Administration from July 2013 to June 2023,and the device causes and clinical manifestations of the adverse events were analyzed.Results:The main device problems of coronary stent adverse events were stenting failure(1301 cases,25.71%),material deformation or bending(761 cases,15.04%),device displacement or dislocation(618 cases,13.26%),etc.Among the injury reports,the main clinical manifestations were thrombosis(159 cases,6.33%),re-occlusion(151 cases,6.01%),angina pectoris(119 cases,4.74%),etc.Among the death reports,the main clinical manifestations were cardiac arrest(138 cases,29.55%),cardiogenic shock(56 cases,11.99%)and cardiac tamponade(44 cases,9.42%).Conclusion:Relevant units should strengthen risk awareness,strengthen monitoring and supervision,improve product quality,and ensure the safe use of coronary stent implantation devices.