The U.S. Food and Drug Administration (FDA) has warned the public that the medical device called the ev3 Onyx Liquid Embolic System might cause fatal side effects.
What Is The ev3 Onyx Liquid Embolic System?
Made and sold by the Covidien subsidiary ev3, the Onyx Liquid Embolic System is used to block the flow of blood to abnormally formed blood vessels that develop in the brain, referred to as “brain arteriovenous malformations” (brain AVMs). When physicians must operate on patients with brain AVMs, they insert a catheter into the brain AVM and inject the Onyx Liquid Embolic System into it. The liquid solidifies when it comes in contact with blood, making removing the brain AVM less likely to result in serious blood loss.
The ev3 Onyx Liquid Embolic System Might Cause Fatal Side Effects
On June 28, 2012, the FDA issued a safety communication warning physicians that “catheter entrapment” might result when using the Onyx Liquid Embolic System. Catheter entrapment means the catheter becomes jammed in the solidified Onyx substance (called the “Onyx plug”) and cannot be easily removed.
Catheter entrapment occurred during clinical trials that ev3 conducted on the Onyx Liquid Embolic System, but—because no further complications occurred—the company didn’t include a catheter entrapment warning in the Onyx Liquid Embolic System’s labeling.
In an FDA safety communication dated November 2012, the agency noted that it had received more than 100 adverse event reports of patients suffering catheter entrapment after being treated with the Onyx Liquid Embolic System for brain AVMs. Those adverse event reports included nine patient fatalities and 54 cases in which the catheter and Onyx plug remained lodged inside the patient.
The following side effects can occur due to catheter entrapment:
- Surgeries to remove the catheter and Onyx plug
- Migration of the Onyx plug to other parts of the body
- Radiation exposure from imaging devices used to locate the catheter and Onyx plug
- Use of antithrombotic drugs to prevent additional blood clots around the Onyx plug
RLG’s ev3 Onyx Liquid Embolic System Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The ev3 Onyx Liquid Embolic System lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an ev3 Onyx Liquid Embolic System lawsuit on your behalf if necessary.
If doctors used the ev3 Onyx Liquid Embolic System to treat you and you believe you were harmed as a result, contact RLG today.