Recently, the FDA sent out a letter to health care providers that gives new safety recommendations for neurovascular stents that are used for stent-assisted coiling (SAC) of brain aneurysms.
According to the FDA, the agency received reports about neurovascular stents that suggest some instances of peri-procedural stroke and/or death might have been related to procedural risks or factors related to the selection of patients. The letter states that patient related factors included those with serious co-morbidities resulting in a reduced life expectancy, and those who were intolerant to required anticoagulation or anti-platelet therapy.
Neurovascular stents used for unruptured brain aneurysms are supposed to treat wide-neck, intracranial, and saccular aneurysms. A wide-neck is defined as a neck with a width less than 4 millimeters or a dome-to-neck ratio greater 2 millimeters. The FDA has approved these types of devices from multiple manufacturers through the Humanitarian Device Exemption (HDE) regulatory pathway.
While neurovascular stents for SAC provide useful options for the treatment of wide-neck brain aneurysms, the procedure itself is not without risks, and careful consideration of the patient and device being used is crucial in order to ensure the benefits outweigh the treatments risks.
Factors that can place a patient at risk include:
- Patient age
- Presence of patient symptoms, such as cranial nerve deficit
- Family history of brain aneurysm(s) or subarachnoid hemorrhage (SAH)
- Prior SAH
- Gender
- Ethnicity
- Tobacco use
- Hypertension
- Location of the brain aneurysm
- Changes over time of size and morphology
New Recommendations
The FDA recommends the following things to health care providers using neurovascular stents for SAC:
- Consider and discuss the benefits and risks of neurovascular stent devices and procedures with patients, including alternative management modalities.
- Patients should be properly informed of the rates of serious adverse events.
- Know that neurovascular stent devices are approved for the treatment of brain aneurysms based on limited characteristics and the size of parent vessels. Read the specific device manufacturer’s product labeling if you need information for use outside of FDA evaluated parameters.
- Don’t use neurovascular stents in patients who don’t qualify for systemic anticoagulation and/or not able to receive anti-platelet medications. Use on these patients might cause serious harm, including ischemic stroke and death.
- Use a neurovascular stent that is the proper length and diameter based on the dimensions of the brain aneurysm and parent vessel.
- You should only use delivery microcatheters that are compatible with the neurovascular stent manufacturer. Consult the manufacturer’s instructions on the device before using it.
- Micro-guidewires and microcatheters can become entangled with stent struts, change stent position, cause vessel injury, or rupture the brain aneurysm when they are manipulated within or passed through the struts of an implanted stent.
- Make sure the specific coil models and sizes chosen are indicated for the embolization of brain aneurysms.
- Always report any adverse events caused from neurovascular stents. In your report, include length of time between the procedure and the event, the type of brain aneurysm that was treated, the location and target vessel dimensions, the size of the aneurysm, the specific device used, and other patient factors related to the treatment.
Have you been injured due to neurovascular stents used for stent-assisted coiling of a brain aneurysm? Contact our team of Kansas City product liability lawyersto set up your free case consultation. We can let you know if you are entitled to financial compensation.