The Food and Drug Administration issued a warning to physicians and patients Monday about the Onyx Liquid Embolic System where the catheter used to deliver the liquid can get stuck inside the patient’s brain.
The product – formerly made by Minnesota-based ev3 – is now part of Covidien which acquired the company in for $2.6 billion in 2010.
The Onyx Liquid Embolic System is intended for patients who have abnormally-formed blood vessels in the brain. These are known as brain arteriovenous malformations or brain AVMs. The Onyx liquid, delivered via a catheter, solidifies when it touches blood, thereby preventing blood flow to the AVMs. The product is used before a physician can surgically remove the malformed blood vessels.
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But, FDA noted that there have been more than 100 reported cases where the catheter was entrapped or stuck in the Onyx implanted material. In some of the cases the catheter could later be removed but in 54 of these, they could not.
The FDA advisory also noted that in the clinical data that ev3 presented before the approval, did acknowedge the chance for the so-called catheter entrapment and that the catheter could be removed albeit with some difficulty. However, the company found no evidence that the catheters could not be removed at all.
The marked discrepancy calls for a change in product labeling, FDA said.
Covidien spokesman David Young said that the company is cooperating with the FDA to correct the problem of labeling immediately. However, he declined to say how many patients have undergone the procedure, which was approved in 2005.
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