FDA将美敦力栓塞装置召回标记为I类-动脉网

FDA tags Medtronic embolisation device recall as Class I

Medical Device Network 等信源发布 2025-03-19 12:00

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Medtronic’s recalled devices are used for brain aneurysm treatment. The estimated prevalence of unruptured intracranial aneurysms (UIAs) in the general population is around 3.2%, with an annual risk of rupture of 2-10%, leading to subarachnoid hemorrhage (SAH).

美敦力召回的设备用于治疗脑动脉瘤。在普通人群中，未破裂颅内动脉瘤（UIA）的估计患病率约为3.2%，其年破裂风险为2-10%，可导致蛛网膜下腔出血（SAH）。

Image credit: Tada Images / Shutterstock

图片来源：Tada Images / Shutterstock

The US Food and Drug Administration (FDA) has tagged Medtronic’s recall of certain Pipeline Vantage embolisation devices as Class I following reports of four patient deaths.

美国食品药品监督管理局（FDA）在收到四例患者死亡报告后，将美敦力公司召回某些Pipeline Vantage栓塞装置的行动标记为I类。

A Class I recall is the most serious type, and designated by the FDA in cases where it concludes there is ‘reasonable probability’ that use or exposure to a given product will cause serious adverse health consequences or death.

一类召回是最严重的类型，由FDA在认定使用或接触某种产品存在“合理可能性”导致严重不良健康后果或死亡的情况下指定。

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The Medtronic Neurovascular recall involves the company’s Pipeline Vantage 027, compatible with 0.027″ inner diameter microcatheters, and Pipeline Vantage 021 for use with 0.021” microcatheters (with both models part of product lots from

美敦力神经血管召回涉及该公司的Pipeline Vantage 027（与内径为0.027英寸的微导管兼容）以及用于0.021英寸微导管的Pipeline Vantage 021（这两款型号均属于产品批次的一部分）。

B317266 through B817292

B317266 至 B817292

）。

Used for treating aneurysms, the devices are inserted into the blood vessels through a small catheter and delivered to the aneurysm location, following which a small, braided tube is placed to block off blood flow to the bulging area.

用于治疗动脉瘤的装置通过小导管插入血管并送达动脉瘤位置，随后放置一个小的编织管以阻断血液流向隆起区域。

Reports surfaced that in the affected product lots of both Pipeline Vantage models, there was a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during aneurysm procedures, resulting in incomplete wall apposition or braid deformation..

有报道称，在受影响的两个Pipeline Vantage型号的产品批次中，设备的柔性编织管部分在动脉瘤手术过程中未能正确附着或保持附着在血管壁上，导致壁贴合不完全或编织变形的发生率较高。

The issue has resulted in 13 reported injuries and four reports of death in relation to Pipeline Vantage 027, and four reported injuries but no deaths with respect to Pipeline Vantage 021. The reports prompted Medtronic’s issuance of an ‘urgent recall notice’ to affected customers in January 2025.

该问题已导致与Pipeline Vantage 027相关的13例报告受伤和4例死亡报告，而与Pipeline Vantage 021相关的4例报告受伤但无死亡报告。这些报告促使美敦力于2025年1月向受影响客户发出了“紧急召回通知”。

The FDA stated that all affected 027 model devices be quarantined and returned to Medtronic, while those using the 021 model should refer to Medtronic’s updated instructions for device use, which the company said includes revisions to help users achieve optimal device size selection and stent braid deployment to “reduce the risk of complications and patient harms” by lowering the incidence of incomplete wall apposition and/or braid deformation..

FDA表示，所有受影响的027型号设备应被隔离并退回美敦力公司，而使用021型号的用户则应参考美敦力公司更新的设备使用说明。该公司称，更新内容包括帮助用户实现最佳设备尺寸选择和支架编织展开的修订，以“降低并发症和患者伤害的风险”，通过减少不完全壁贴合和/或编织变形的发生率来实现。

Medtronic’s revised instructions for Pipeline Vantage 021 add guidance around how physicians can best use a balance of device tension and compression to achieve adequate wall apposition with the device. The instructions also include warnings about the consequences of incomplete wall apposition and suboptimal deployment, along with a callout around the increased risk of braid deformation in females, especially in those younger than 45 years of age..

美敦力修订了Pipeline Vantage 021的使用说明，新增了关于医生如何最佳地利用设备张力和压缩的平衡来实现设备与血管壁充分贴合的指导。说明中还包含关于不完全贴壁和次优释放后果的警告，并特别指出了女性患者，尤其是45岁以下的女性，出现编织结构变形的风险增加。

This month,

本月，

Philips pulled its endovascular implant

飞利浦撤回了其血管内植入物

from the market after the device was hit with a Class I recall tag from the FDA.

在该设备被FDA贴上一级召回标签后，就退出了市场。

A recent study published in the