Covidien catheters have been linked to nine deaths and a number of other incidents, prompting the U.S. Food & Drug Administration (FDA) to issue an alert on its web site. The catheters are manufactured by a unit of the device maker and are meant to block the flow of blood to abnormal brain blood vessels, explained the Sun Chronicle.
The FDA’s alert notes that some catheters have broken or become entrapped in the body after treatment with the Onyx Liquid Embolic System, which is manufactured by Covidien unit, ev3. The Onyx system is used before surgery to stop blood flow to abnormally formed parts of blood vessels, explained the Sun Chronicle. The agency now recommends that health care providers carefully select patients for the procedure and adhere to manufacturer instructions for removal of any entrapped catheter.
The system is usually used to treat patients diagnosed with brain arteriovenous malformations (brain AVMs), the FDA noted. The system is meant to reduce bleeding and surgical complications when the brain AVM is removed, which typically occurs a few days following Onyx treatment. During the Onyx embolization procedure, the physician uses fluoroscopy to guide the catheter to the site where the Onyx material will be implanted. Onyx material is then injected through the catheter into the blood vessels of the brain at the location of the AVM, solidifying when the material comes in contact with blood so that blood flow to the brain AVM can be blocked.
The FDA Alert indicates that the FDA has received more than 100 reported cases of catheter breakage that may be related to catheter entrapment, said the Sun Chronicle. It was impossible to remove the catheter and a portion, as well as the Onyx material, remained implanted in 54 of the cases. The agency approved changes in physician and patient labeling this April to indicate catheter entrapment risks.
Complications from catheter entrapment can be serious, the regulatory agency said, and include potential hemorrhage and death, as well as parts of the Onyx plug or catheter migrating to other parts of the body, said the Sun Chronicle. Should catheter entrapment occur, the patient 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 patient exposure to radiation.
The potential for catheter entrapment only occurs during implantation, according to the agency’s alert, which can be accessed at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm310121.htm. Patients treated with Onyx, but who suffered no complications at the time, are not at risk.
This is not the first time this year that Covidien has had issues with one of its products. Earlier this year, we wrote that Covidien announced a recall on all lots of its Duet TRS Universal Straight and Articulating Single Use Loading Units after receiving 13 reports of serious injuries and three reports of death when the units were used following thoracic surgery. Covidien said the device should not be used following thoracic surgery and believes using this device after a thoracic surgery could cause life-threatening complications including serious injuries to the “adjacent anatomical structures” in the throat.