AUDIENCE: Neurology, Risk Manager
ISSUE: FDA received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.
BACKGROUND: Neurovascular stents used for SAC are intended to treat wide-neck, intracranial, saccular aneurysms, arising from various sized parent vessel diameters depending on the manufacturers’ intended use (e.g., > 2 millimeters and < 4.5 millimeters). Wide-neck is defined as having a neck width > 4 millimeters or a dome-to-neck ratio < 2. These devices are available from multiple manufacturers and have been approved by FDA through the Humanitarian Device Exemption (HDE) regulatory pathway, after demonstrating safety and probable benefit for their intended use.
RECOMMENDATION: See Medical Device Safety: Letters to Healthcare Providers for a complete list of recommendations. When using neurovascular stents for SAC, the FDA recommends that health care providers:
- Consider and discuss with your patients the benefits and risks of neurovascular stent devices and procedures, as well as the availability of any alternative management modalitie.
- For smaller brain aneurysms, or for patients with reduced life expectancy, in the absence of other risk factors, the risks of treatment may outweigh the benefits of treatment. Therefore, the patient should be properly informed of the rates of serious adverse events and the rupture risk as part of the decision making to undergo intervention.
- Be aware that neurovascular stent devices for SAC are approved for the treatment of brain aneurysms of limited characteristics and parent vessel sizes, and the FDA has not evaluated the safety and probable benefit outside those parameters. Consult the specific device manufacturer’s product labeling for further information.
- Avoid use of neurovascular stents for SAC in patients who are not candidates for systemic anticoagulation and/or not able to receive anti-platelet medications as use of the devices require peri-procedural anticoagulation and/or anti-platelet therapy. Thrombosis in or around the stent may result in serious harm, including ischemic stroke and death.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Progra:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/08/2018 – Letters to Healthcare Providers – FDA]