Neurovascular Stents Lawsuit
Our lawyers are investigating claims alleging that neurovascular stents used for stent-assisted coiling (SAC) may put patients at an increased risk of stroke or death. These stents offer a non-surgical method for treating brain aneurysms, but the procedure may not be safe for everyone.
What is a Neurovascular Stent?
Neurovascular stent-assisted coiling treats saccular, intracranial, and wide-neck aneurysms.
Neurovascular stents are available from several manufacturers, including Stryker Neurovascular and Covidien, and are used in treating saccular, intracranial, and wide-neck aneurysms.
An aneurysm is a weak spot in the blood vessel wall which causes the vessel to bulge outward like a bubble. Though an aneurysm can occur in any blood vessel, this condition is especially dangerous in the brain because if the weakened vessel bursts, it can cause uncontrollable, often fatal, brain bleeding.
In neurovascular SAC procedures, doctors weave a microcatheter through the patient's groin to the aneurysm. Once there, a coil is released and inserted inside the weak and bulging blood vessel to seal it off and prevent more blood from entering the aneurysm. The stent holds the coil in place.
What Are the Risks of Stent-Assisted Coiling Procedures?
“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."
Though stent-assisted coiling devices were approved by the FDA through the Humanitarian Device Exception, that does not mean that they are safe for everyone.
In fact, on May 8, 2018, the FDA issued a safety alert to all health providers. This letter was published after the FDA received reports that doctors performed the procedure on high-risk patients who couldn’t tolerate the treatment.
The letter warned, “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."
Neurovascular stent procedures require anticoagulant and antiplatelet therapies, so patients who can’t undergo these blood-thinning regimens should not have the procedure.
Another risk is that the device may not work and the brain aneurysm may still rupture. Sometimes the microcatheters may become entangled with the stent struts, causing the stent to change position, injure the blood vessel, or rupture the brain aneurysm.
Some patients are more susceptible to brain aneurysms. Health care providers shouldn’t recommend the procedure for patients with the following risk factors for ruptured aneurysms:
- Older than 40 years of age
- Family history of subarachnoid hemorrhages (SAH)
- Previous SAH
- Tobacco use
- Ethnicity: African Americans have the highest risk factor for SAH
- Gender: Women have a greater risk for SAH
Patients should be properly informed of the serious risks for this procedure and the possibility of aneurysm rupture, which could lead to stroke or death.
The FDA also warns against unnecessarily performing this procedure on patients with small brain aneurysms or a lowered life expectancy. Smaller aneurysms, such as those less than five millimeters, are at a much lower rate of rupture than large (11-25 millimeters) or giant aneurysms (more than 25 millimeters). Smaller aneurysms can be treated more conservatively, and may not even need a stent procedure.
“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 said.
Are you Eligible for a Neurovascular Stent Lawsuit?
You may be eligible for a lawsuit if you or a loved one underwent a stent-assisted coiling procedure, and suffered a stroke or death during or after the procedure.
A lawsuit against the stent manufacturer may help recover compensation for the following:
- Medical bills
- Loss of wages (past and future)
- Pain and suffering
We'll Help You Fight Back
Some patients were selected to undergo this operation despite these known risks and the increased risk for stroke or death. If you or your loved one were injured or died during or directly after the neurovascular stent with SAC procedure, you may qualify to participate in a class action lawsuit against the medical device manufacturer.
Our firm frequently goes up against big corporations in order to fight for the everyday individual—and we’ve won. It’s possible you may be entitled to compensation for your pain and suffering. Contact us to see if you’re eligible today.
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