首页|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

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

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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.
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.

coronary artery stentadverse eventsrisk factor

张频、郑佳俊、余超、江涵

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南昌医学院公共卫生学院(江西 南昌 330052)

南昌大学第二附属医院心胸外科(江西 南昌 330006)

冠状动脉支架 不良事件 风险因素

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(19)