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Updated: Jul 17, 2025

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与AMPLATZER左心房附属体封闭输送系统相关的不良事件:食品和药物管理局MAUDE数据库研究MAUDE数据库研究

Jakrin Kewcharoen¹, Kuldeep Shah², Rahul Bhardwaj¹

¹Division of Cardiology, Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, California, USA.

Journal of cardiovascular electrophysiology

|September 8, 2023

概括

报告了与AMPLATZER左心房尾阻塞 (LAAO) 输送系统相关的不良事件,包括气栓塞和血管并发症. 未来设备技术和操作员经验的改进可能会降低这些风险.

科学领域:

心脏病学心脏病学
医疗器械医疗器械
患者安全患者安全

背景情况:

具有双重闭塞机制的Amplatzer Amulet设备于2021年8月获得FDA批准,用于皮肤穿透的左心房尾闭塞 (LAAO).
对于安普拉特泽心脏插头和安普拉特泽护身符设备输送系统,现实世界的安全数据有限.

研究的目的:

评估与安普拉特泽LAAO输送系统相关的不良事件的类型和频率.
分析来自FDA制造商和用户设施设备体验 (MAUDE) 数据库的安全数据.

主要方法:

在FDA的MAUDE数据库中进行了全面的搜索.
收集了2013年2月至2023年3月期间报告的不良事件的数据.

主要成果:

总共有59个不良事件被确定,主要是与相关的 (58个事件).
常见的不良事件包括气栓塞 (19%),血栓 (13.8%),曲的 (10.3%),和变形 (8.6%).
患者相关的不良事件包括心周溢出 (22.4%),血管并发症 (20.7%),以及设备脱离 (5.2%).

结论:

与AMPLATZER LAAO输送罩相关的不良事件越来越多地被报告.
设备技术的改进,可转向的外套和增强的操作体验有望减轻这些并发症.

关键词:

护身符护身符护身符莫德 (Maude) 是一个女士.不良事件不良事件不良事件送货的传递.

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