FDA发布早期警示：爱德华兹二尖瓣输送系统球囊充盈时破裂 已报告1死1重伤、四批次停用退回
美国食品药品监督管理局（FDA）10月15日发布早期警示（Early Alert），称爱德华兹生命科学（Edwards Lifesciences）用于SAPIEN M3经导管二尖瓣置换系统的部分Commander M输送系统存在潜在高风险问题，器械与放射卫生中心（CDRH）已就此向公众通报，FDA正在审查相关信息。
FDA称，爱德华兹已向受影响客户发函，建议把涉事输送系统从使用和销售场所撤下。受影响的Commander M输送系统共四个批次，批号为67718561、67804014、67887043和67887044；其他批号的产品不受此次处理影响，可继续使用。
公司10月5日致函全部受影响客户，要求把警示转达院内相关临床人员、清查库存并撤下涉事产品，并配合公司代表办理退回。
据FDA公布的信息，公司共收到三起球囊在充盈过程中破裂的报告。球囊破裂可能造成栓塞，也可能导致器械无法经引导鞘回收，从而需要追加干预、包括外科手术；而接受这类经导管二尖瓣置换的患者群体本身通常被判定不适合外科手术，这类追加干预带有严重不良后果的高风险。截至10月5日，公司报告与该问题相关的死亡1例、严重伤害1例。
FDA表示将继续审查这一潜在高风险器械问题，并在获得重要新信息时更新通报。
FDA Early Alert: Edwards Mitral Valve Delivery System Balloons Burst During Inflation; One Death, One Serious Injury Reported, Four Lots Pulled
The U.S. Food and Drug Administration on October 15 issued an Early Alert saying that certain Commander M delivery systems made by Edwards Lifesciences for use with the SAPIEN M3 transcatheter mitral valve replacement system present a potentially high-risk issue. The Center for Devices and Radiological Health issued the alert, and the FDA said it is reviewing information about the problem.
According to the FDA, Edwards has written to affected customers recommending that the delivery systems be removed from where they are used or sold. The affected Commander M systems cover four lots: 67718561, 67804014, 67887043 and 67887044. Units with other lot numbers are not impacted and can continue to be used.
On October 5 the company sent the letter to all affected customers, asking them to share the notice with appropriate clinical staff, search inventory for the affected product, remove it, and work with their Edwards representative to return it.
Edwards has received three reports of balloons bursting during inflation, the FDA said. A balloon burst can cause embolism or leave the device unable to be retrieved through the guide sheath, which may require additional intervention, including surgery — interventions that carry a high risk for this patient population, which is deemed unsuitable for surgery. As of October 5, the company had reported one death and one serious injury associated with the issue.
The FDA said it will keep the public informed and update its alert as significant new information becomes available.
发布：GSM·美国（发布链接）
图片来源：心导管实验室介入手术资料画面（非涉事器械）· 美国海军医学 摄，公共领域（维基共享资源）
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