Abstract 186: Adverse events and failures with Cerenovus CEREGLIDE 71 Intermediate Catheter: An analytic review of the FDA MAUDE database

Introduction/PurposeRecent literature has suggested that direct aspiration catheters as a first‐pass approach are a viable alternative to stent retriever‐based methods in mechanical thrombectomy for acute ischemic stroke. The Cereglide 71 aspiration catheter, launched by Cerenovus with TruCourse Technology, is specifically designed to navigate challenging anatomical conditions with reliable trackability and durable delivery.This study aims to evaluate the safety of the Cereglide 71 aspiration catheter by analyzing reports and data from the Manufacturer and User Facility Device Experience (MAUDE) database.MethodsAll patient‐ and device‐related reports from November 2023 onwards were obtained, screened, and compiled from the MAUDE database using the codes NRY and QJP. The reports were filtered to distinguish between patient‐related (PR) and device‐related (DR) events. Data filtering, organization, and analysis were performed using Microsoft Excel 2021 and Jamovi. Descriptive statistics were used to assess reporting frequency.ResultsDuring the study period, a total of 36 medical device reports were collected, comprising 27 device‐related problems and 13 patient‐related adverse events.The patient's adverse events included multiple cases of intracranial hemorrhage 5 (38%), thromboembolism 3 (23%), vascular dissections 2 (15%), ischemic stroke 1 (7%), carotid‐cavernous fistula 2 (15%), and cerebral vasospasm (15%). The device problems involved issues such as material twisting, bending, and deformation, often leading to cracks or stretching. Difficulties in advancing or retracting the device were frequently reported, along with fluid or blood leaks, component detachment, and accessory incompatibility. The reports lacked demographic data, with only three reports including patient age and gender. Nineteen reports were submitted by physicians, and only 12 catheters were returned to the manufacturer for further analysis.ConclusionThis study emphasizes the importance of improved post‐market surveillance to enhance patient outcomes. To the best of our knowledge, this is the first report detailing complications related to the Cereglide 71 aspiration catheter as documented in the FDA MAUDE database. By utilizing real‐world data, the study identifies key complications relevant to clinical practice, Surgeons should be mindful of the range of potential complications to better manage patient expectations and optimize surgical preparedness.