Parker Waichman LLP is investigating potential personal injury and defective medical device claims related to adverse events associated with the use of Neurovascular Stents for Stent-Assisted Coiling (SAC) for the treatment of unruptured brain aneurysms. The Food and Drug Administration (FDA) has received adverse event reports suggesting these stent devices are linked to stroke and/or death.
What Are Neurovascular Stents Used for Stent-Assisted Coiling (SAC)?
According to the FDA, neurovascular stents used for stent-assisted coiling (SAC) are medical devices intended to treat “wide-neck, intracranial, saccular aneurysms, arising from various sized parent vessel diameters depending on the manufacturers’ intended use.” These stent devices are manufactured by multiple companies and have been approved by the FDA through the Humanitarian Device Exemption (HDE) pathway.
FDA Safety Alert Relating to Neurovascular Stents for Stent-Assisted Coiling (SAC)
On May 8, 2018, the FDA issued a safety alert for doctors and patients regarding recent reports linking neurovascular stents for stent-assisted coiling (SAC) to peri-operative stroke and/or death. This means that some patients suffered a stroke and/or death near or at the time the devices are being used to treat unruptured brain aneurysms.
Based on adverse event reports, the FDA believes that patients suffering from stroke, death, and other injuries are related to factors such as procedural risks and patient selection. For example, some adverse event reports suggest that patients with co-morbidities (i.e., other health conditions) that result in a reduced life expectancy or patients who are unable to take anticoagulants or undergo anti-platelet therapy may be at greater risk of suffering stroke and/or death relating to the use of neurovascular stents.
FDA Recommends Health Care Providers Discuss Potential Adverse Events with Patients
Because of recent reports of serious injuries such as stroke and death associated with the use of neurovascular stents for stent-assisted coiling (SAC) in the treatment of unruptured aneurysms, the FDA recommends that health care providers inform their patients about the risks and benefits associated with the use of these medical devices. A discussion of such risks and benefits includes the following:
• Patients with smaller brain aneurysms or patients with a reduced life expectancy should be informed that the risk of using neurovascular stent devices for the treatment of unruptured aneurysms may outweigh the benefits;
• Patients should be informed that alternative treatment options may exist that are less risky and equally or more beneficial than the use of neurovascular stent devices;
• Patients should be informed that neurovascular stent devices for stent-assisted coiling (SAC) are only approved by the FDA for the treatment of specific types of brain aneurysms, and that the FDA has not investigated the use of these medical devices for other types of brain aneurysms; and
• Patients who are unable to take anticoagulants or undergo anti-platelet treatment are not good candidates for the use of neurovascular stents for stent-assisted coiling (SAC) as the use of these medical devices requires patients to be on anticoagulants and/or undergo anti-platelet therapy at the time of operation.
Because of the FDA’s newly reported adverse events associated with the use of neurovascular stents for stent-assisted coiling (SAC), Parker Waichman LLP is investigating potential personal injury and product liability claims, such as stroke and/or death relating to the use of these medical devices.
Filing a Neurovascular Stent Lawsuit
Parker Waichman has represented clients in pharmaceutical injury lawsuits for decades. If you or someone you know is interested in filing a Neurovascular Stent Lawsuit please visit this page Neurovascular Stent Lawsuits, or contact Parker Waichman LLP at the firm’s website at yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).