225 - Insights from the FDA MAUDE Database on Adverse Events Related to the Use of Stent Retriever Mechanical Thrombectomy Devices for Acute Ischemic Stroke

Purpose: Stent retrievers have transformed the management of acute ischemic stroke by enabling rapid and effective mechanical thrombectomy to restore blood flow in occluded cerebral vessels. Among these, Stryker’s Trevo retrievers are the most widely used due to their efficacy and broad clinical adoption. Despite their benefits, these procedures carry risks of device related malfunctions and patient complications. This study aimed to analyze adverse events reported in the FDA MAUDE database to better define the safety profile of stent retrievers and inform improvements in device design and clinical practice.

Materials and Methods: The FDA MAUDE database was queried for reports between December 2019 and August 2025 under the product class “Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment” {1}. Reports were reviewed to exclude duplicates and incomplete entries. Device malfunctions and patient related problems were categorized and frequencies were calculated.

Results: Seventy nine reports were included. Device fracture, breakage, or separation occurred in 67.1% of cases, frequently leading to retained foreign bodies (31.6%). Difficult removal or entrapment within the catheter was reported in 11.4%, often related to tortuous vascular anatomy. Hemorrhagic events were noted in 16.5% of patients, with intracranial hemorrhage accounting for 30.7% of these and hemorrhagic stroke for 7.6%. Vessel perforation (6.3%) and vasospasm (3.8%) were also observed. Neurologic complications, including paralysis, paresis, and dysphagia, were documented in 6.3%. Less frequent complications included vessel occlusion, thrombosis, embolism, pulmonary edema, and fistula formation.

Conclusion: Stent retrievers for mechanical thrombectomy in acute ischemic stroke are associated with a notable risk of device fracture and retained fragments, as well as hemorrhagic and vascular complications. Patient specific vascular anatomy plays a key role in device failure. These findings highlight the need for meticulous procedural planning, careful device selection, and continued refinements in device design to minimize adverse outcomes and enhance safety in thrombectomy procedures.