FDA Issues a Class I Recall of Zilver® PTX™ Drug-Eluting Peripheral Stent
Due to the seriousness of the risks involved with the use of the new Zilver® PTX™ Drug-Eluting Peripheral Stent, the FDA has issued a Class I Recall. The Zilver® PTX™ is a self-expanding stent designed to be implanted in an artery of the thigh. The outside of the device is coated with the drug Paclitaxel, which helps prevent the artery from narrowing.
Cook Medical, the manufacturer of the stent, has received 13 reports of instances where the stent’s delivery system separated at the tip of the inner catheter. The defect could lead to vascular occlusion, thrombosis, amputation, possible cardiac arrest, and even death. Surgery would likely be necessary to remove the catheter tip from the patient to avoid these potential complications. According to a recent report, there has already been one reported death and one instance of a patient suffering an unspecified adverse event as a result of the stent’s defective delivery system.
Cook Medical has taken measures to contact all affected customers. The recall affects only the PTX™ version of the stent manufactured from December 1, 2012 through April 16, 2013, and not the bare metal version, which uses a different delivery system.
Legal Disclaimer: The choice of a lawyer is an important decision and should not be based solely on advertisements.