Work

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

Year: 2025

Type: article

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.

Source: Journal of Cerebrovascular and Endovascular Neurosurgery

DOI: 10.7461/jcen.2025.e2025.01.004

Authors: Ibraheem Alkhawaldeh, Ahmed Aljabali, Mostafa Hossam El din Moawad, Mahmoud Abualhayjaa, Hamza K. Alsalhi

Institutions: Mutah University, Jordan University of Science and Technology, Alexandria University, Hashemite University

Language: English

Topic: Intracranial Aneurysms: Treatment and Complications

Subfield: Neurology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: diamond

OpenAlex ID: W4414519993