June 29, 2012 — Today the U.S. Food and Drug Administration (FDA) announced new warnings and guidelines regarding the Onyx Liquid Embolic System. Since 2005, the agency has received 9 reports of death and more than 100 reports of catheter breakage. In some cases, broken pieces of the device remain entrapped in the patient’s brain, causing long-term complications that could include brain hemorrhage and death.
The Onyx system is a treatment for a disorder called arteriovenous malformations (or AVMs), in which blood vessels in the brain are malformed. The Onyx system uses a catheter, which is a long flexible tube that is inserted in the groin and guided to the brain. Inside the brain, a physician injects the Onyx liquid into the brain. When it comes in contact with blood, the liquid hardens and forms a plug, which seals off the malformed blood vessels.
Unfortunately, in some cases, the catheter can become stuck in the hardened liquid material, making it difficult or impossible to remove. The catheter can easily become broken when a physician is trying to remove it from the patient’s brain. Of more than 100 adverse event reports, in more than half of the cases, the physician was forced to leave broken pieces of the catheter or plug implanted inside the patient’s brain.
The Onyx system is not intended to be a long-term implant, and patients who have broken pieces of the catheter or plug inside their brain are at risk of numerous long-term complications. This includes a life-threatening cerebral hemorrhage, which can cause injury, disability, or death. Fragments of the catheter may also move to other parts of the brain or body, causing serious internal damage. Patients will probably need to take a blood-thinning medication to reduce the risk of blood clots forming inside the brain around the implanted device. Patients will also probably need to undergo multiple high-radiation MRIs, which could increase their long-term risk of cancer.
When the manufacturers of the Onyx system were seeking FDA approval of the device, they warned that some physicians had difficulty removing the catheter after the procedure. However, there were no serious adverse events. The original instructions and warnings for the device did not include risk information about the catheter becoming trapped in a patient’s brain.
The FDA is updating the label on the device to include this risk information. They are specifically advising that doctors only perform procedures using the device when they are prepared for an emergency situation in which the catheter breaks inside the patient’s brain.
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