A device made by Covidien, used to treat a rare blood vessel deformation, is the subject of a new Food Drug Administration (FDA) warning.
The Covidien device is a spongy piece used to prevent blood flow to malformed tangles of blood vessels in the brain while a patient is waiting for surgery. But the FDA said Thursday in a notice posted to the agency’s website that the Covidien device has been linked to some patient injury and even death, due to the fact it is not intended as a long-term therapy.
According to the notice, Covidien’s Catheter Entrapment with the ev3 Onyx Liquid Embolic System is unlikely to interfere with AVM removal — but the catheter can become entrapped, with serious consequences:
“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.”
The FDA warning continues:
“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.”
The official warning about the Covidien device can be viewed over at the FDA’s site, and advises that additional interventions, including increased exposure to radiation, can result if a catheter becomes entrapped. The FDA also encourages reporting of adverse effects associated with the Covidien catheter in the event entrapment occurs.