FDA Warns About Onyx Liquid Embolic System Catheter Breakage, Deaths
The Onyx Liquid Embolic System (“Onyx”) could increase the risk of catheter breakage and fatalities, according to a new FDA warning.
A safety alert issued by the FDA warns that use of Onyx has been linked to reports of catheter entrapment, which could lead to breakage, hemorrhage and possibly death. Catheter breakage could also result in migration of the Onyx plug or catheter fragment to other parts of the body.
If catheters do break, patients may be required to undergo one or more imaging procedures to locate a piece of the catheter and Onyx plug, increasing their exposure to radiation. Antithrombotic drugs to prevent blood clots around the catheter may also be necessary.
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Learn MoreSince 2005, the FDA has received more than 100 reported cases involving problems with the Onyx Liquid Embolic System, including nine patient deaths, where the catheter broke and it may be related to catheter entrapment.
In some cases, the catheter could be removed. However, in at least 54 of these cases, it was not possible to remove the catheter. As a result, part of the catheter and the implanted Onyx material (Onyx plug) remained implanted in the patient. Onyx has not been tested or approved as a long-term implant.
For neuro interventionalists treating patients with brain arteriovenous malformations (brain AVMs), catheter entrapment is unlikely to affect the ability to surgically remove the patient’s AVM. However, since neither Onyx nor the catheter is intended to be long-term implants, patients may need additional medical interventions to have the catheter removed if it becomes entrapped.
In April 2012, the FDA approved changes to the physician and patient labeling that reflect the risks related to catheter entrapment with Onyx. The labeling also includes recommendations to help minimize the risk of entrapment. According to the FDA, physicians should expect to see this labeling in new orders for Onyx.
The Onyx Liquid Embolic System is a liquid material used to block blood flow in abnormally formed blood vessels in the brain before their surgical removal. A catheter is used to deliver the Onyx liquid to the blood vessel(s) in the brain.
Onyx is intended to reduce bleeding and surgical complications when the brain AVM is removed, typically a few days after treatment with Onyx. 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 injected through the catheter into the blood vessels of the brain at the location of the AVM. The Onyx material solidifies when it comes in contact with blood in order to block blood flow to the brain AVM.
Fluoroscopy is a type of medical imaging that shows a continuous x-ray image on a monitor, much like an x-ray movie. It is used to diagnose or treat patients by displaying the movement of a body part or of an instrument or dye (contrast agent) through the body. During this procedure, an x-ray beam is passed through the body. The image is transmitted to a monitor so that the body part and its motion can be seen in detail.
The FDA recommends health care providers and neuro interventionalists select patients carefully, after reviewing the most recent device labeling and instructions. Onyx is only approved for use in patients who will undergo surgical removal of the treated brain AVM.
For patients, the potential for catheter entrapment occurs only during implantation. Patients treated with Onyx who did not experience this complication at the time of implantation are not at risk.
Analysis of adverse event reports submitted about Onyx and catheters used to deliver the Onyx material has been conducted and monitoring will continue, says the FDA.
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3 Comments
CaroleFebruary 4, 2022 at 5:38 pm
My husband had the same procedure with the AVM and Onyx 18 implant. He also was in the ICU for about 2 weeks and had a stroke during the procedure and he could not talk, walk not even feed himself due to the tremors (shaking) of his head, arms, hands and was throwing up as well. It has been since 2017 and this is 2022 and he still has the speach issues, walkiing, gait, headaches, and is very dis[Show More]My husband had the same procedure with the AVM and Onyx 18 implant. He also was in the ICU for about 2 weeks and had a stroke during the procedure and he could not talk, walk not even feed himself due to the tremors (shaking) of his head, arms, hands and was throwing up as well. It has been since 2017 and this is 2022 and he still has the speach issues, walkiing, gait, headaches, and is very disabled now.. Before this procedure he had an anurism burst and had brain surgery and he came out of that after a year completely recovered and then this procedure was done and now he is all messed up and also has the short term and recently long term memory as well. We were not told that this procedure was a high risk, in fact we were told a very small percentage of issues were about 10% and not 50% like I have found on a lot of sites. Also is this going to come back and have to be done again ? because I have read this is not a long term implant. Do you know this to be true ?
PamelaSeptember 17, 2020 at 4:59 am
I’m sorry to hear this happened to you too Heather. It is a living nightmare! My husband has experienced much of the same. He has undergone 3 attempts at treating his AVM. July, August and October 4th of 2019. The last resulting in a bleed, though the dr stated to me after the procedure, that though he was very very careful, as he was backing the catheter out, it stuck to the Onyx and caused the [Show More]I’m sorry to hear this happened to you too Heather. It is a living nightmare! My husband has experienced much of the same. He has undergone 3 attempts at treating his AVM. July, August and October 4th of 2019. The last resulting in a bleed, though the dr stated to me after the procedure, that though he was very very careful, as he was backing the catheter out, it stuck to the Onyx and caused the small bleed. Hours later he was in ICU, vomiting and left for me to care for alone. Soon he was no longer responding and had a stroke, requiring intubation and another procedure to place an EVD thru his scull to save his life. We spent 12 days and 11 nights for what was said to require a few hr. surgery and overnight! The day after Christmas he had an MRI. His January dr appointment informed us of the fact that a small section did not get blocked off with the Onyx. He has areas of brain damage. The dr recommend yet another angiogram and treatment with guided radiation. My husband said no more. He has short term memory loss, level 9 daily headache and balance and gait instability. He is disabled now.
HeatherJuly 14, 2019 at 10:23 pm
I had 2 onyx embolizations performed in October of 2007. My first one went great but the second the catheter became entrapped. I was told I was the first for this to happen to. Also, I was supposed to have this done instead of removing my AVM, not preparation to remove my AVM. I only had to have my AVM removed because the catheter got stuck. After my surgeries and while I was in the hospital the c[Show More]I had 2 onyx embolizations performed in October of 2007. My first one went great but the second the catheter became entrapped. I was told I was the first for this to happen to. Also, I was supposed to have this done instead of removing my AVM, not preparation to remove my AVM. I only had to have my AVM removed because the catheter got stuck. After my surgeries and while I was in the hospital the catheter caused me to have a stroke. I had to learn how to speak, read, and write again. Several months later, I knew something wasn’t right and in May 2008 they found they missed a part of my AVM. I had my 4th surgery. Ever since, I have chronic migraines and fibromyalgia. I couldn’t begin to count how many EEG and CT and MRIs I have had done to my body. It is very hard being a burden to my family.