FDA: Covidien Brain Device Linked to Nine Deaths

A Covidien medical device used during brain surgery has been linked to nine deaths, according to a warning from the Food and Drug Administration (FDA).

Made by Covidien’s ev3 unit, the device consists of a catheter that delivers a liquid material called Onyx to block blood flow in abnormally formed blood vessels in the brain prior to their surgical removal.

Since 2005, the FDA received more than 100 reported cases—including the nine deaths – of catheter breakage that may be related to entrapment of the device in the brain. In at least 54 incidents, it was not possible to remove the catheter, so part of the device and the Onyx material remained implanted in the patient.

In April, the FDA approved changes to the device’s labeling to reflect the risks related to catheter entrapment.

Complications from catheter entrapment can be serious, including hemorrhage and death. Other complications include migration of the Onyx plug or catheter fragment to other parts of the body, according to the FDA.

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.

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