Regulatory News In Brief

FDA issued a safety communication June 28 warning physicians and patients about the risk of catheter entrapment with the Onyx liquid embolic system, manufactured by Covidien’s ev3 unit. The liquid material is used to block blood flow in abnormally formed brain vessels, known as brain arteriovenous malformations. A catheter is used to deliver the Onyx liquid to the vessels. Since Jan. 1, 2005, FDA has learned of more than 100 cases, including nine deaths, of catheter breakage that may be related to catheter entrapment. In 54 cases, the catheter could not be removed, so part of the catheter and the implanted Onyx material remained in the patient. The most serious complications include hemorrhage and death. FDA notes that neither Onyx nor the catheter is meant to be a long-term implant. FDA approved updated labeling for the product in April to convey risks related to the catheter entrapment.

The communication came only a few days after Covidien was in the spotlight for another serious product problem. On June 25, FDA's website listed a June 14 agency warning letter...