Adverse events and failures with Cerenovus CEREGLIDE 71 Intermediate Catheter: An analytic review of the FDA MAUDE database.

Journal of cerebrovascular and endovascular neurosurgery Pub Date : 2025-09-25 DOI:10.7461/jcen.2025.E2025.01.004

Ibraheem Alkhawaldeh, Ahmed Aljabali, Mostafa Hossam El Din Moawad, Mahmoud Abualhayjaa, Hamza K Alsalhi

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引用次数: 0

Abstract

Objective: To assess the safety and performance of the Cereglide 71 aspiration catheter, launched in February 2024, by analyzing adverse events from the Manufacturer and User Facility Device Experience (MAUDE) database.

Methods: Reports from the MAUDE database (February 2024 onward) were analyzed using Microsoft Excel and Jamovi, with 36 reports reviewed-27 device-related and 14 patient-related.

Results: The most common device-related issues were cracks (8 occurrences), material bending (6), and deformation/stretching (5). Adverse events included thromboembolism (4 cases), intracranial hemorrhage (2), carotid-cavernous fistula (2), and cerebral vasospasm (2). The most common indication was middle cerebral artery stroke (9 cases).

Conclusions: This study highlights the importance of post-market surveillance to improve patient outcomes, identifying key complications that require careful consideration in clinical practice. This is the first report on complications related to the Cereglide 71 aspiration catheter from the FDA MAUDE database.

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Cerenovus CEREGLIDE 71中间导管的不良事件和失败：FDA MAUDE数据库的分析回顾

目的：通过分析制造商和用户设施设备体验（MAUDE）数据库中的不良事件，评估于2024年2月推出的Cereglide 71误吸导管的安全性和性能。方法：使用Microsoft Excel和Jamovi对来自MAUDE数据库（2024年2月起）的36份报告进行分析，其中27份与器械相关，14份与患者相关。结果：最常见的器械相关问题是裂纹（8例），材料弯曲（6例）和变形/拉伸（5例）。不良事件包括血栓栓塞（4例）、颅内出血（2例）、颈动脉-海绵窦瘘（2例）、脑血管痉挛（2例）。最常见的适应症为大脑中动脉卒中（9例）。结论：本研究强调了上市后监测对改善患者预后的重要性，确定了临床实践中需要仔细考虑的关键并发症。这是FDA MAUDE数据库中有关Cereglide 71误吸导管并发症的第一篇报道。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of cerebrovascular and endovascular neurosurgery

CiteScore

1.10

自引率

0.00%

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