临床试验致一人死亡,美敦力召回主动脉移植物支架

2021-03-07 医谷网 医谷网

医疗器械制造商美敦力公司(Medtronic Plc)发公告称,该公司主动面向全球范围内召回未使用的Medtronic Valiant NavionTM胸腔支架移植系统,并通知医生立即停止使用该设备,

医疗器械制造商美敦力公司(Medtronic Plc)发公告称,该公司主动面向全球范围内召回未使用的Medtronic Valiant NavionTM胸腔支架移植系统,并通知医生立即停止使用该设备,直至另行通知。

同时,美敦力已经与美国食品和药物管理局(FDA)以及世界各地的其他监管机构联系,分享与这一问题有关的信息。该公司表示,将继续与监管部门就这一全球自愿召回进行直接合作。

美敦力召回胸腔支架移植系统是基于一项最近在Valiant Evo全球临床试验,发现了三名患者出现支架折断,一名患者死亡。根据美敦力公司的说法,在三例支架折断的案例中,其中两个已经确认了IIIb型泄漏,即断裂导致纤维管撕裂,血液从植入物的通道中流出。

在这些观察之后,一个独立的影像实验室回顾了所有入组Valiant Evo全球临床试验患者的可用影像。在进一步分析图像后发现,在87例患者中有7例支架环扩大宽度超过了植入物的设计规范。这些观察需要进一步评估以确定潜在的临床重要性。

据了解,此次美敦力涉事胸腔支架移植Valiant系统设计原理是从内部加固虚弱的主动脉,并减轻血管壁上的压力。该装置通过微创导管穿过人体动脉,以避免开放手术,并部署了一个由金属支架支撑的合成纤维管。

截至目前,美敦力向医生发送了书面信函,建议医生回顾性检查所有使用Valiant Navion胸腔支架移植系统治疗的患者的可用图像,特别注意支架断裂和IIIb型内漏。美敦力敦促医生遵循最佳临床实践,并根据Valiant Navion胸腔支架移植物系统使用说明书(IFU)中的成像建议,对患者进行至少每年一次的随访评估。

医谷根据国家药监局召回事件梳理,美敦力今年已先后召回药物灌注系统(注册证号:国械注进20173545069)、胸主动脉覆膜支架系统Valiant Thoracic Stent Graft with the Captivia Delivery System(注册证号:国械注进20143135591)两款在中国使用产品,此次美敦力涉事胸腔支架移植Valiant系统尚未在中国大陆销售。

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    2021-04-22 xuyong535
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