The agency said better risk management and patient selection may help avoid strokes and/or deaths related to the devices.
The US Food and Drug Administration (FDA) has issued a safety alert and a new list of recommendations for the use of neurovascular stents for stent-assisted coiling (SAC) in patients with unruptured brain aneurysms. The recommendations were issued after the agency received reports that some periprocedural strokes and/or deaths may have been related to procedural risks or improperly selected patients.
Neurovascular stents used for coiling are intended for the treatment of wide-neck, intracranial, saccular aneurysms, arising from parent vessels of various diameters, depending on each stent manufacturer’s intended use.
“Neurovascular stents for SAC provide important options for the treatment of wide-neck brain aneurysms, and their technology continues to evolve,” William Maisel, MD, MPH, the Deputy Center Director for Science in the FDA’s Center for Devices and Radiological Health, wrote in a letter to healthcare professionals. “However, these procedures are not without risks, and careful patient selection and proper device use are critical to ensure that the benefits to the patient outweigh the risk of treatment.”
The FDA recommended discussing risks and benefits associated with neurovascular stent devices and procedures to ensure that patients are properly informed about serious adverse events and rupture risk, as well as the availability of any alternative management modalities. The agency emphasized that each stent device is approved only for brain aneurysms of limited characteristics and parent-vessel sizes, and the safety of these devices has not been evaluated outside of those parameters. Clinicians should consult the specific device manufacturer’s product labeling for further information before use.
The FDA also recommends:
- Avoiding neurovascular stents for SAC in patients who are not candidates for systemic anticoagulation and/or not able to receive antiplatelet medications.
- Selecting a neurovascular stent for SAC of proper length and diameter based on the dimensions of the brain aneurysm and parent vessel.
- Only using delivery microcatheters that have been found compatible for use by the neurovascular stent manufacturer.
- Carefully observing micro-guidewires and microcatheters when they are manipulated within or passed through the struts of an implanted stent.
- Carefully observing embolization coil(s) when they are manipulated within a brain aneurysm and avoid coil prolapse through stent struts.
- Reporting any adverse events associated with neurovascular stents for SAC.
The FDA’s letter noted that many patients with unruptured brain aneurysms can be managed with routine monitoring and follow-up, depending on their individual risk factors for aneurysm rupture.
US Food and Drug Administration. Neurovascular stents used for stent-assisted coiling of unruptured brain aneurysms: letter to health care providers. Published on: May 8, 2018. Accessed on: May 17, 2018.