Neurovascular Stent Lawsuit
Patients who are at risk for a ruptured aneurysm should be aware that the FDA recently warned of serious side effects that may occur with treatments involving neurovascular stents.
These stents are sometimes used to treat unruptured brain aneurysms, but there have been reports of some patients suffering from stroke and/or death after treatment. The FDA has asked physicians to be particularly careful in choosing which patients are the best candidates for these procedures.
Chaffin Luhana is now investigating cases in which patients were injured and/or killed because of neurovascular stents.
FDA Warns About Neurovascular Stents and Risk of Stroke
The SAC procedure may save some lives, or allow patients to live more normal lives, but in some cases, it may be dangerous. On May 8, 2018, the FDA warned about reports they’d received associating the use of neurovascular stents in SAC procedures with stroke and/or death. These incidents were related to certain factors, including:
- patients with serious co-morbidities (other health conditions) resulting in a reduced life expectancy, and
- patients who were intolerant to anticoagulation or anti-platelet therapy.
In other words, patients with other health conditions that reduced their life expectancy, or who couldn’t take blood-thinning drugs, seemed to be at a higher risk for these complications.
In a letter to health care providers, the FDA provided recommendations regarding patient selection and device use. They noted that though neurovascular stents for SAC provide important options for the treatment of wide-neck brain aneurysms, “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 added that many patients with aneurysms can be treated conservatively with regular follow-ups and routine monitoring and that doctors should carefully consider factors that are known to increase the risk of rupture when selecting patients who may be good candidates for neurovascular stent treatment. Those with smaller aneurysms, for example, may be fine with more conservative treatment, while those with larger aneurysms have a heightened risk of rupture.
The FDA further recommended that doctors:
- Consider the benefits and risks of treatment, and discuss these with patients.
- Refrain from using this treatment in patients who can’t tolerate blood-thinning medications, as these are necessary after neurovascular stent SAC. Patients who can’t take these medications are more at risk for blood clots forming around the stent, which can cause stroke and death.
- Be sure to select a stent the right size and diameter based on the dimensions of the brain aneurysm and the vessel in which it’s occurring, and to be sure to follow the manufacturer’s guidance.
- Carefully observe the coils as they are inserted to make sure they don’t come back through the stent, where they could cause a dangerous blood clot.
- Report any adverse events associated with neurovascular stents for SAC to the FDA’s MedWatch system.
What is an Aneurysm?
An aneurysm is a bulge of blood that forms in an artery because the artery wall is weakened. You can picture the artery like a hose, and the blood like the water traveling through that hose. If a small area of that hose starts to weaken, the water may expand outward in that location, creating a bulge.
The same thing can happen in an artery anywhere in the body. An aneurysm may occur in one of the major arteries attached to the heart, in an artery in the brain, or in other arteries in the leg, intestine, or spleen. The bulge itself may occur in a soccer-ball-like pattern, expanding on all sides, or may form a bulge on one side only.
An aneurysm may develop slowly, over a period of years, or may develop more quickly. Usually, there are no symptoms, but if an aneurysm occurs in an area close to the surface of the skin, there may be swelling and a visible, throbbing mass there. If an aneurysm suddenly expands or ruptures (breaks open), however, the following symptoms may develop:
- Pain in the area of the bulge
- Rapid heart rate
- Low blood pressure
- Clammy skin
- Nausea and vomiting
The larger the aneurysm, the more likely it is to eventually rupture. A ruptured aneurysm can cause internal bleeding, which can be extremely dangerous. An aneurysm that bursts in the aorta—the artery that starts in the heart and passes through the chest and abdomen—can quickly become fatal. An aneurysm that ruptures in an artery that runs to the brain can become fatal within 24 hours. Aneurysms occurring in other areas of the body are less likely to rupture.
How Are Aneurysms Treated?
Doctors typically start by treating an aneurysm conservatively by simply monitoring it to see how it behaves. If there are no symptoms, and the aneurysm is not large or growing, doctors are likely to provide medications and other preventative measures to prevent it from rupturing.
In some cases, however, more serious treatment is needed. If the aneurysm is growing quickly, causing pain or other symptoms, and the patient is considered a “good candidate” for treatment, the doctor may decide on surgery of which there are two general types:
- Traditional surgery using a standard incision to repair the artery with a stent.
- Endovascular surgery, which is considered “minimally invasive” and uses only a small incision and a catheter through which a stent is inserted into the artery.
The second surgery is called “endovascular stent grafting,” or “endovascular aneurysm repair (EVAR).” This is a newer form of treatment for aneurysms that helps reinforce the weakened wall of the affected artery. The “stent” is a metal mesh device in the shape of a pipe or tube that is placed inside the artery where the aneurysm is located. The stent provides support for the blood vessel and helps prevent rupture. When the treatment is successful, the bulging area will shrink around the stent, forming a newer, stronger repaired area.
There are risks with this procedure, though. Complications may include:
- Blood leaks around the graft or stent area.
- The stent moves away from its initial location.
- The stent breaks.
- The aneurysm ruptures anyway.
- The area becomes infected.
What is a Neurovascular Stent?
The neurovascular stents that the FDA refers to in its warning are used in a treatment called “stent-assisted coiling (SAC),” which is a minimally invasive procedure used in patients with a very particular type of aneurysm called a “wide-neck” aneurysm.
The term “wide-neck” describes the bulge itself, not the patient’s neck. It means that the width at the base of the bulge, also called the “neck,” is at least 4 millimeters wide, or at least twice as wide as the height of the bulge. Simply put, it means the aneurysm is wide and large and thus has a higher risk of rupturing.
Wide-neck aneurysms present unique challenges for surgeons. To treat many aneurysms, surgeons use a small incision and a catheter through which they release platinum coils into the aneurysm. These are long strands of very thin, coiled wire, sort of like guitar strings, but flexible. These coils fill the aneurysm and induce blood clotting, basically “blocking off” or “sealing off” the opening in the aneurysm so it doesn’t grow anymore.
Releasing these coils alone isn’t enough in a wide-neck aneurysm, however. Because the opening is so wide, the coils may not stay in place once implanted, and may simply fall out of the aneurysm. Therefore, surgeons use a neurovascular stent to help keep the coils in place.
During a SAC procedure, the surgeon makes a small incision and then threads a catheter through to reach the aneurysm and then implants the neurovascular stent. It goes into the neck of the aneurysm, and extends past the opening on both sides, helping to support the blood vessel. Next, the surgeon releases the platinum coils into the aneurysm. The stent acts as a scaffold to hold the coils inside the aneurysm so they don’t fall back out into the blood vessel.
Over time, as the area heals, the blood is diverted away from the weakened area of the artery and the rupture is prevented.
Neurovascular Stent SAC Lawsuits
If you or a loved one went through a neurovascular stent SAC and suffered a stroke or died, you may be eligible to file a neurovascular stent lawsuit. Chaffin Luhana is investigating these cases and invites you to call today at 1-888-480-1123.