Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.
Catheter Cardiovasc Interv. 2019 Jul 1;94(1):157-164. doi: 10.1002/ccd.28297. Epub 2019 Apr 15.
To assess the commonly reported complications and failure modes for FilterWire EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
EPDs prevent distal embolization of atheroembolic materials during percutaneous interventions resulting in reduced microvascular obstruction and improved microcirculation while maintaining tissue perfusion. The FilterWire EZ EPD (Boston Scientific, Natick, MA) is approved for use in interventions of de novo saphenous vein grafts (SVG) and carotid artery stenosis. Robust data on the commonly reported complications and failure modes associated with the FilterWire EZ device are limited.
The MAUDE database was queried from September 1, 2008, through September 30, 2018, for FilterWire EZ system, yielding 474 reports. After exclusion of duplicate and incomplete reports, 464 device reports were included in the final analysis.
Device-related adverse events were most commonly reported for carotid (n = 281) and SVG (n = 101) interventions. The most commonly reported major complications were: ischemic stroke (n = 57), vessel perforation or dissection (n = 12), death (n = 8), and myocardial infarction (n = 5). Minor complications included: hypotension (n = 68), bradycardia (n = 41), and vasospasm (n = 27). The most commonly reported failure modes were: detachment and/or damage of the device components (n = 118), device entrapment (n = 90), and stent-related issues (n = 46).
Analysis of the MAUDE dataset is helpful in identifying the commonly reported adverse events and failure modes of FilterWire EZ devices. This platform serves as an important tool for both physicians and manufacturers to optimize device performance and clinical outcomes.
通过分析食品和药物管理局（FDA）制造商和用户设施设备经验（MAUDE）数据库中的上市后监测数据，评估 FilterWireEZ 栓塞保护装置（EPD）常见的报告并发症和故障模式。
EPD 可防止经皮介入过程中动脉粥样硬化栓子材料的远端栓塞，从而减少微血管阻塞并改善微循环，同时保持组织灌注。FilterWireEZ EPD（波士顿科学公司，马萨诸塞州纳提克）获准用于新出现的隐静脉移植物（SVG）和颈动脉狭窄的介入治疗。与 FilterWireEZ 设备相关的常见报告并发症和故障模式的相关数据有限。
从 2008 年 9 月 1 日至 2018 年 9 月 30 日，在 MAUDE 数据库中查询 FilterWireEZ 系统，共产生 474 份报告。排除重复和不完整的报告后，最终分析包括 464 份设备报告。
与设备相关的不良事件最常报告用于颈动脉（n=281）和 SVG（n=101）介入。最常报告的主要并发症包括：缺血性中风（n=57）、血管穿孔或夹层（n=12）、死亡（n=8）和心肌梗死（n=5）。较小的并发症包括：低血压（n=68）、心动过缓（n=41）和血管痉挛（n=27）。最常报告的故障模式是：设备组件的分离和/或损坏（n=118）、设备嵌顿（n=90）和支架相关问题（n=46）。
分析 MAUDE 数据集有助于识别 FilterWireEZ 设备常见的不良事件和故障模式。该平台为医生和制造商优化设备性能和临床结果提供了重要工具。
