A product meant to save lives could instead potentially do the opposite according to a new warning from the Food and Drug Administration.
The safety warning concerns use of a product known as the Onyx Liquid Embolic System, which is made by ev3. An implantation of this system works by using a catheter to send the liquid to various abnormally formed blood vessels in a patient’s brain. Prior to a surgery designed to remove these malformations, Onyx is supposed to stop blood from flowing to the vessels so that they can be taken out.
However, a label change is in order due to the risks associated with catheter entrapment when using this Onyx system. The catheter implanted can actually become lodged within the Onyx liquid. This could cause the Onyx plug or the catheter itself to travel to various other parts of a person’s body. Complications can thus arise, including hemorrhage and a possible fatality.
Finding a migrated catheter might require imaging scans, increasing radiation exposure, and correcting the problem could involve the patient taking antithrombotic drugs which could stave off blood clots around the entrapped catheter. Entrapment could also require a further medical procedure to remove the trapped catheter.
Healthcare professionals are being instructed to follow relevant care instructions, only selecting for the procedure those patients that pass the threshold set by the latest labeling guidelines. Doctors should also be ready to go into action should entrapment present itself. Medical care providers should contact MedWatch should an adverse event make its presence known.