FDA Safety Alert: ev3 Onyx Liquid Embolic System Catheter Risks
The U.S. Food and Drug Administration (FDA) recently issued a patient safety alert for the Onyx Liquid Embolic System (Onyx) noting nine patient deaths have occurred and more than 100 incidents of catheter entrapment have been reported.
How it Works
Onyx is manufactured by ev3, a medical device maker that specializes in stents, catheters, and embolic protection devices. Onyx is used to treat both aneurysms (weakened balloon-like portions of a vessel) and arteriovenous malformations (AVMs – the abnormal growing together for arteries and veins forming a web-like mass). The Onyx liquid is injected through a catheter into the affected area of the brain where it begins to solidify, blocking the flow of blood to the damaged area so the AVM or aneurysm can be surgically removed.
The Onyx system was approved under the FDA’s Humanitarian Device Exemption program on April 11, 2007. In April, 2012, the FDA approved changes to the product labeling reflecting the risks of catheter entrapment, including recommendations to help minimize the risk of entrapment.
Catheter entrapment is a serious safety risk associated with the Onyx Liquid Embolic System. This can happen when the catheter, or a part of it, adheres to the Onyx material and breaks off during the procedure. Serious complications such as hemorrhage, migration of the Onyx material or catheter fragment, or death may occur. Patients with catheter entrapment may need to take additional drugs to prevent blood clots around the catheter, and may need to undergo one or more procedures to locate and remove a piece of the catheter.
If you or someone you know has suffered a serious injury as a result of treatment for an AVM or aneurysm with the Onyx Liquid Embolic System, contact us. Our personal injury and product liability attorneys have experience handling cases involving defective medical devices and can discuss your legal rights and options.