INTRODUCTION
The treatment of acute ischaemic stroke has been revolutionised by mechanical thrombectomy (MT), especially for patients with large vessel occlusions (LVO). Aspiration thrombectomy, particularly with large-bore aspiration catheters, has become a very attractive substitute for stent retrievers among the endovascular procedures that are currently available. Aspiration catheters, which frequently call for fewer device passes and shorter procedure times, have the potential to enable faster, easier, and just as effective revascularisation [4,25]. With successful recanalisation rates ranging from 89% to 96% in studies involving devices like the REACT and Sofia catheters, the A Direct Aspiration First Pass Technique (ADAPT) has gained popularity in clinical practice [16,19]. Better navigation, clot engagement, and clinical outcomes have been facilitated by advancements in catheter design, such as bevelled tips, larger inner diameters, and reinforced delivery systems [12,30].
An estimated 7.8 million new cases of ischaemic stroke were reported worldwide in 2021, indicating that the disease’s burden is still significant [31]. Due to ageing populations and enduring vascular risk factors, absolute case numbers are still increasing even though age-standardized incidence rates have decreased in some areas [7,13]. According to estimates, 10-15% of patients who have an acute ischaemic stroke qualify for MT, and demographic changes are expected to result in a 40% increase in treatment demand by 2040 [20,22]. Therefore, public health priorities include increasing access to MT and improving procedural efficiency.
With comparatively comparable rates of TICI 2b/3 reperfusion, functional independence, and safety outcomes, numerous clinical trials and meta-analyses have assessed the relative effectiveness of ADAPT and stent retrievers [21]. However, some studies have linked ADAPT to a lower incidence of distal emboli and faster recanalisation [14]. The decision between aspiration and stent retriever techniques is frequently impacted by anatomical complexity, clot characteristics, and operator preference; however, randomised evidence is still scarce [28,29].
There are still significant gaps in the post-market safety data for more recent aspiration catheters, despite encouraging outcomes in early-phase trials and observational studies. Rare or delayed complications might go unnoticed in controlled settings, even though registries and trials like ASTER and COMPASS offer insights into efficacy [24]. In addition to indicating high recanalisation rates, early assessments of large-bore catheters such as React 71, Sofia Plus, and CEREGLIDE 71 also raise concerns regarding complications like intracranial haemorrhage, thromboembolism, and catheter tip breakage [27]. Furthermore, the generalisability of many studies is diminished by their small sample sizes, brief follow-up times, and selective populations.
Post-market surveillance systems, like the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, are essential in this regard. MAUDE provides early warning indicators for device-related issues by gathering real-world safety data across a range of environments and operator skill levels, in contrast to clinical trials [5]. Underreporting, non-standardized data fields, and a lack of denominator data are some of MAUDE’s significant drawbacks, which make it difficult to determine actual event rates or conduct systematic device comparisons [2]. However, with careful interpretation, it continues to be a useful supplement to registry-based and pre-market research, particularly for novel or developing devices.
In February 2024, the Cereglide 71 catheter launched with TruCourse Technology to enhance flexibility, navigation, and clot aspiration. It supports direct aspiration and can be used with stent retrievers for versatile thrombectomy. Characterising the post-market safety profile of aspiration devices, such as the CEREGLIDE 71 catheter, is urgently needed due to the rapid introduction of newer aspiration devices and the widespread use of aspiration thrombectomy. Procedures can be improved, device design can be improved, and patient safety can be improved by routinely understanding device-related malfunctions and related patient complications. Early post-market surveillance is both necessary and timely because there are currently no systematic analyses of real-world complications associated with the CEREGLIDE 71 catheter in the literature.
By examining adverse events recorded in the FDA MAUDE database after the Cerenovus CEREGLIDE 71 Intermediate Catheter was introduced to the market in 2024, this study seeks to assess the safety and effectiveness of the device. We compare our results with published clinical data, give a descriptive overview of complications related to both patients and devices, and identify important areas for further safety monitoring and device optimisation.
MATERIALS AND METHODS
This study used the MAUDE database, maintained by the FDA, to monitor adverse events related to medical devices approved for use in the United States. Manufacturers, importers, and device-user facilities are required to report to the MAUDE database, while healthcare professionals, patients, and consumers can do so voluntarily. Since the MAUDE database contains de-identified data and is publicly accessible, ethical approval was not necessary.
The initial search for adverse event reports related to the Cereglide 71 Intermediate Catheter involved using the keywords “Cereglide 71,” “Cereglide 071,” and “Cereglide catheter.” Reports from the FDA MAUDE database began appearing in February 2024. The device fault codes “NRY” (catheter malfunction) and “QJP” (device difficult to position), as well as the company name “Cerenovus,” were used in both basic and advanced search queries.
Initially, 118 reports were identified. After review, 74 were excluded because they concerned different devices, and 8 were excluded due to insufficient information or duplicates.
This left 44 reports specifically about the Cereglide 71 Intermediate Catheter. Out of these, 36 met the inclusion criteria and were included in the final analysis (Fig. 1). Two authors (IMK, HKA) reviewed the report reference numbers and event descriptions to identify duplicates and similar cases. If a report mentioned more than one patient, the cases were separated into individual reports. A third author (MHEM) reviewed and verified the results.
The reports were then filtered to distinguish between patient-related (PR) and device-related (DR) events. Data filtering, organization, and analysis were conducted using Microsoft Excel 2021 and Jamovi, with descriptive statistics applied to evaluate reporting frequency.
RESULTS
During the study period, a total of 36 medical device reports were collected after screening from all reports submitted. These included 27 device-related reports with 47 problems and 14 patient-related adverse events. Six reports involved both patient and device problems, and 14 reports contained multiple device-related events.
Patients experienced various adverse events, such as four cases of thromboembolism, two intracranial hemorrhages (one subarachnoid hemorrhage [SAH] and one acute intracranial hemorrhage [aICH]), two carotid-cavernous fistulas (CCF), two episodes of cerebral vasospasm affecting the internal carotid artery (ICA), and vascular dissections involving the ICA and right vertebral artery. Additionally, one patient suffered an ischemic stroke.
The most commonly reported device issues were cracks (8 cases), followed by twisted or bent material (6 cases), and deformation or stretching of material (5 cases). These problems highlight concerns about the device’s structural integrity during use. Other issues, such as physical resistance, fluid or blood leaks, and retraction difficulties, were less frequent but still notable. For details on all reported device events, see Table 1 & Fig. 2.
The primary indication for device use was middle cerebral artery (MCA) stroke, with nine reported cases, followed by internal carotid artery (ICA) stroke with three cases. Three additional reports only specified stroke without indicating the type. Less common were basilar artery strokes (2 cases) and vertebral artery strokes (1 case). Some reports involved combined stroke presentations, including one case involving both the MCA and anterior cerebral artery (ACA), and another involving the MCA and ICA.
Unfortunately, the reports lacked demographic data, with only three reports including patient age and gender. Physicians submitted nineteen reports, and only 12 catheters were returned to the manufacturer for further analysis.
DISCUSSION
Main findings and significance
Based on reports from the FDA MAUDE database, this study is the first to analyze post-market safety signals related to the recently introduced Cerenovus CEREGLIDE 71 Intermediate Catheter. While thromboembolism, intracranial hemorrhage, and arterial injury were the most common patient-related complications, structural failures such as cracks, deformation, stretching, and retraction issues were the most frequently reported device-related problems. Although the catheter has advanced navigational capabilities, its practical use reveals a risk profile that warrants further research. Because they provide early safety signals for a new thrombectomy device, these findings are clinically important and will assist regulatory agencies, device designers, and clinicians in making informed decisions.
Comparison with existing literature
Our findings are consistent with an expanding body of research on the risks associated with large-bore aspiration catheters used in mechanical thrombectomy. Previous reports of structural failures in a variety of devices have included coil separation, kinking, and catheter breakage [1,8]. Patients with stenotic or tortuous vasculature, where device stress is increased, should be especially concerned about these mechanical problems. In fact, ICA tortuosity has been linked to increased hemorrhagic risks, longer procedure times, and a lower first-pass effect [3,11]. According to our data, these anatomical difficulties make it more difficult to advance and retrieve a catheter, which raises the possibility of vascular trauma and device failure.
The observed vasospasm and thromboembolic events could be caused by endothelial irritation or catheter-induced clot fragmentation, both of which have been previously reported in previous research [17,26]. Despite the fact that ADAPT has been linked to lower symptomatic ICH rates and faster reperfusion than stent retrievers [10,23], the device-related thromboembolism in our series might be a reflection of actual handling or procedure errors.
Our results are in line with previous meta-analyses that found several contributing factors, such as multiple device passes, distal occlusions, and intraprocedural complications, and that showed symptomatic ICH rates of 7-8% in relation to hemorrhagic complications [9,15]. Our findings highlight that inappropriate catheter manipulation or undetected vessel pathology may still result in vessel rupture or dissection, despite some research suggesting that aspiration-based techniques lower the risk of sICH [10].
It is also critical to compare our findings with the encouraging preliminary results reported in the only available literature on real-world use of the CEREGLIDE 71—a multi-center retrospective study by Majidi et al., presented as a conference abstract. Despite 81.7% of cases involving challenging anatomies, the catheter achieved a 99.1% navigation success rate. Reperfusion outcomes included a 35% first-pass mTICI ≥2c and a 95% final mTICI ≥2b, with direct aspiration alone effective in 60% of patients. The safety profile was favorable, with no device-related adverse events and low rates of symptomatic intracranial hemorrhage (3.3%) and vessel dissection (1.7%) [18]. The catheter is also set to be included in the upcoming phase of the CERENOVUS EXCELLENT Registry. In contrast to the varied and uncontrolled scenarios represented in the MAUDE database, the Majidi study reflects controlled institutional settings, typically involving experienced operators and selective patient inclusion.
Study implications
This study raises awareness of potential complications beyond initial trial environments and provides timely insights into the CEREGLIDE 71 catheter’s real-world safety profile. It emphasises the value of procedural vigilance for interventionalists, particularly when managing resistance or navigating complex anatomy. These findings might also be helpful to device makers in improving the flexibility and durability of designs for upcoming catheter generations. Furthermore, by showing actual complication patterns, our findings can help guide informed consent conversations, particularly with high-risk patients.
This study supports the need for post-market surveillance systems to supplement pre-market assessments, which might miss uncommon or delayed device-related risks, from a policy perspective. MAUDE is a crucial but underutilised tool for early adverse event detection, particularly during the launch phase of new devices.
Limitations and strengths
The MAUDE database’s inherent limitations, such as clinicians’ voluntary reporting, unstructured or incomplete event narratives, the absence of denominator data (such as the number of devices used), and possible duplication, all affect our analysis [6,32]. Therefore, it is not appropriate to use our results to compare complication rates across devices or to interpret them as incidence rates.
The study does, however, have some significant advantages. It offers an early real-world safety profile for a recently released device and is the first to systematically analyse adverse events related to CEREGLIDE 71. It is a useful resource for academic and clinical audiences due to its systematic review, categorisation of adverse events, and contextualisation with other literature. Furthermore, by providing a more comprehensive perspective on device performance, the study supports the results of real-world registries (like the EXCELLENT registry) and early clinical trials.
Future directions
Several future directions should be considered to enhance device safety evaluation. First, data consistency, completeness, and comparability across reports could be improved by establishing standardized reporting templates within the MAUDE database. Strengthening surveillance and providing more insightful cross-device analysis may also be supported by an improved adverse event reporting structure. Second, researchers could combine structured, prospective outcomes with passive surveillance by integrating MAUDE reports with real-world registry data, such as the EXCELLENT and COMPASS registries. This integration would offer a more comprehensive view of device safety and efficacy. Third, extensive real-world datasets should be utilized to develop predictive models for device failure, particularly in cases involving tortuous vascular anatomy. These models could assist physicians in risk assessment and pre-procedural planning. Lastly, creating prospective, multicenter registries focused exclusively on large-bore aspiration catheters is justified. To better evaluate device performance across diverse clinical settings, these registries should stratify patients based on procedural variations, operator experience, and anatomical complexity. Long-term outcome studies and ongoing safety monitoring will be essential as large-bore aspiration technologies evolve, ensuring patient safety and supporting innovation.
CONCLUSIONS
The Cereglide 71 catheter, when used in ADAPT techniques, offers additional advantages for mechanical thrombectomy, although it is linked to various complications. Recognizing these complications by reviewing the reports documented in the FDA MAUDE database boosts awareness of their potential occurrences. This understanding makes it essential to adopt specific surgical techniques to reduce risks.
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