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FDA Warns Surgeons on eve3’s Onyx
FDA is warning surgeons about ev3’s Onyx Liquid Embolic System and its potential for catheter entrapment. When approved in 2005, clinical data submitted included cases where the delivery catheter was difficult to remove, but in all cases the catheter was removed without any adverse patient events, an agency notice says. “The original product labeling did not reflect the risks related to catheter entrapment but new labeling will include these risks as well as recommendations to help minimize that risk,” it says.
Jim Dickinson
July 25, 2012
1 Min Read
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Onyx is a liquid material used to block blood flow in abnormally formed blood vessels in the brain know as brain arteriovenous malformations before their surgical removal. The catheter is used to deliver the Onyx liquid to the blood vessel in the brain.
Since 2005, the agency says it has received more than 100 reported cases, including nine patient deaths, involving catheter breakage that may be related to catheter entrapment. “In some cases the catheter could be removed,” it says. “In at least 54 of these cases, it was not possible to remove the catheter, so part of the catheter and the implanted Onyx material (Onyx plug) remained implanted in the patient.”
The notice also reminds surgeons that if the catheter becomes entrapped, they should follow the manufacturer’s instructions for removing it.
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