Regulatory Focus™ > News Articles > US Regulators Issue Warning About Implantable Device

US Regulators Issue Warning About Implantable Device

Posted 29 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) issued a warning on Friday, 29 June regarding an implantable medical device manufactured by Covidien Plc subsidiary ev3's Onyx Liquid Embolic System, which federal regulators said has been associated with at least nine patients deaths and dozens of adverse events.

The device is used to block the flow of blood in affected blood vessels in patients with brain arteriovenous malformations (AVMs) before the vessels are surgically removed. FDA explained adverse event reports indicate dozens of instances in which the device could not be removed and had to be left in the patient.

FDA said the devices are not intended for long-term implantation, and noted the serious risks associated with "catheter entrapment," including hemorrhage and death. The agency also said catheters could break, causing fragments to migrate to "other parts of the body."

While ev3's premarketing data submission to FDA had highlighted similar issues, all devices in the clinical trial had been successfully removed from patients despite being "difficult to remove." The agency ordered changes to the product's patient and physician labeling in April 2012, and is now recommending further precautions based on the risks associated with Onyx.

US regulators stressed the need for physicians to follow the manufacturers' specific instructions on how to remove an entrapped catheter. "Aggressive attempts to remove the catheter can result in catheter breakage or brain hemorrhage," FDA wrote.

The US regulator said it would "continue to monitor adverse events associated with [Onyx], and will make available any new information that might affect their use."

Read more:

FDA - FDA Safety Communication: Catheter Entrapment with the ev3 Onyx Liquid Embolic System

FDA - ev3 Onyx Liquid Embolic System: Safety Communication - Risk of Catheter Entrapment

Regulatory Focus newsletters

All the biggest regulatory news and happenings.