FDA Issues Warning of Covidien Brain Device Linked to 9 Deaths

The Food and Drug Administration has issued a warning to physicians and patients about a .

The Onyx Liquid Embolic System has an issue where the catheter used to deliver the liquid can get stuck inside the patient’s brain.

The product is not one manufactured at the company's , but is linked to nine deaths, according to Blomberg.

In fact, the product is one inherited– formerly made by Minnesota-based ev3 – which Covidien acquired  for $2.6 billion in 2010, according to New York Times.

The the liquid device is intended for patients who have abnormally-formed blood vessels in the brain. These are known asbrain arteriovenous malformations (AVMs). The Onyx liquid, delivered via a catheter, solidifies when it touches blood, preventing blood flow to the AVMs. The product is used before a physician can surgically remove the malformed blood vessels.

Below is the FDA's Summary of Problem and Scope:
Since Jan. 1, 2005, the FDA has received more than 100 reported cases, including nine patient deaths, of catheter breakage that may be related to catheter entrapment. In some cases the catheter could be removed. In at least 54 of these cases, it was not possible to remove the catheter, so part of the catheter and the implanted Onyx material (Onyx plug) remained implanted in the patient.

Catheter entrapment is unlikely to affect the physician’s ability to surgically remove the patient’s AVM. However, neither Onyx nor the catheter is intended be a long-term implant, and patients may need additional medical interventions to have the catheter removed if it becomes entrapped.

Complications associated with catheter entrapment can be serious. The most serious complications include hemorrhage and death. Other complications include migration of the Onyx plug or catheter fragment to other parts of the body. Patients with catheter entrapment may need to take antithrombotic drugs to prevent blood clots around the catheter, and may need to undergo one or more imaging procedures to locate a piece of the catheter and Onyx plug, increasing their exposure to radiation.

In April 2012, the FDA approved changes to the physician and patient labeling that reflect the risks related to catheter entrapment. The labeling also includes recommendations to help minimize the risk of entrapment. Physicians should expect to see this labeling in new orders of Onyx.

Covidien spokesman David Young said that the company is cooperating with the FDA to correct the problem of labeling immediately, according to Med City News.

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