, Department of Neurological Surgery, Rutgers New Jersey Medical School Newark, New Jersey, United States
Introduction: The utilization of Intracranial flow diverters for intracranial aneurysms has increased significantly since its introduction. The most common associated complications are still under investigation. The objective of this study is to describe and characterize device-related complications and patient adverse events related to intracranial flow diverters.
Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for all reports on device-related complications and adverse events involving the use of intracranial flow diverters used in ESS from 2016 to 2021. Reported problems and events were reviewed and categorized.
Results: There were 13 device-related complications and 39 patient adverse events reported in total from 3,602 reports. The most common device-related complications were activation failure (n = 1485, 34.0%), break, flake, deformation, fracture, collapse, twist, bend, delamination (n = 515, 11.8%), and physical resistance and sticking (n = 394, 15.1%). The most common patient-related complications were hemorrhage/Infarction (n = 336, 7.3%), thrombosis, embolism, thromboembolism (n = 247, 5.3%), and neurological deficit/dysfunction (n = 230, 5.0%). However, 27.7% of reports had no device-related complications and 54.8% of reports had no patient adverse events reported. There was a 9.4% average increase of grand total adverse events from 2016 to 2021.
Conclusion : The most commonly reported adverse events were hemorrhage or infarction, thrombosis, embolism, thromboembolism, and neurological deficit/dysfunction. An increased awareness of the complications associated with intracranial flow diverters can be used to better inform patients during the consenting process as well as neurological surgeons in their surgical decision making.
