基于美国MAUDE数据库的冠状动脉支架不良事件及影响因素分析  

Analysis of Adverse Events and Influencing Factors of Coronary Artery Stents Based on FDA MAUDE Database

作　　者：张频 郑佳俊 余超 江涵[2] ZHANG Pin;ZHENG Jia-jun;YU Chao;JIANG Han(School of Public Health,Nanchang Medical College,Jiangxi Nanchang 330052;Department of Cardiothoracic Surgery,the Second Affiliated Hospital of Nanchang University,Jiangxi Nanchang 330006)

机构地区：[1]南昌医学院公共卫生学院,江西南昌330052 [2]南昌大学第二附属医院心胸外科,江西南昌330006

出　　处：《中国医疗器械信息》2024年第19期59-62,共4页China Medical Device Information

基　　金：江西省自然科学基金重点项目(项目名称:NSCLC术后生理-心理-社会综合肺康复的CRM-Nomogram预测模型构建和预后评估,项目编号:20202ACBL206016)。

摘　　要：目的:分析冠状动脉支架不良事件发生情况及相关问题,为其安全提供建议。方法:收集2013年7月~2023年6月美国食品药品监督管理局MAUDE数据库中5060例冠状动脉支架不良事件有关报告,分析其不良事件发生的设备原因及患者临床表现。结果:冠状动脉支架不良事件设备问题主要为支架未能推进(1301例,25.71%)、材料发生变形或弯曲(761例,15.04%)、设备移位或脱位(618例,13.26%)等。伤害报告中患者临床表现主要为血栓形成(159例,6.33%)、再闭塞(151例,6.01%)、心绞痛(119例,4.74%)等;死亡报告中患者临床表现主要为心脏骤停(138例,29.55%)、心源性休克(56例,11.99%)、心脏填塞(44例,9.42%)等。结论:相关单位应加强风险意识,强化监测监管力度,提升产品质量,保障冠状动脉支架植入性器械的安全使用。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.

关 键 词：冠状动脉支架 不良事件 风险因素 

分 类 号：TH778[机械工程—仪器科学与技术]