Zilver PTX Stent Recall Issued Due to Tip Separation Risk

All Zilver PTX drug eluting stents have been recalled due to a faulty delivery system, which may not meet government standards, resulting in at least one patient death and other complaints.  

The Zilver PTX Drug Eluting Stent recall was announced by the FDA on April 24, due to the potential that the delivery system’s tip may separate from the catheter, posing a risk of removal surgery, vascular occlusion, thrombosis, amputation, cardiac arrest, and even death.

At least 13 complaints of problems with Zilver PTX stents have been received by the manufacturer, including at least 2 cases involving inner delivery catheter breakage. At least one of those patients died following the Zilver PTX stent complications.

The recalled Zilver PTX stents are small mesh tubes with an outer drug coating used to help prevent an artery from narrowing. The stents are implanted by a physician by making a small incision in the groin region where the stent is inserted and guides a catheter to the appropriate location in the artery to allow blood flow and prevent common circulatory problems.

The recall includes all sizes, diameters, and lot numbers of Zilver PTX drug eluding stent manufactured by Cook Inc. of Limerick, Ireland from December 13, 2012 through April 16, 2013. The stents were approved for sale in at least 54 countries including the United States, Japan, Australia, and Brazil.

The delivery system tip has been deemed to not meet the established design criteria and is being thoroughly investigated for further issues that may arise from the inner delivery systems and Cook Inc. announced there is a 0.043 occurrence rate that the delivery system tip may separate.

The vice president of Cook Inc. released a statement saying that if patients have had the Zilver PTX drug eluting stent implanted and the delivery system was removed, there is no risk to those patients nor to those with the “bare metal” version of Cook Medical’s Zilver Flex stent.

The FDA announced that consignees should immediately stop using the device, quarantine any remaining inventory and return it to Cook Inc. for credit. Any adverse events or problems arising from the recalled stents should be reported to Cook Medical Customer Relations at (800) 457-4500 or 1-812-339-2235 Monday through Friday between 7:30 a.m. and 5:00 p.m. Eastern time or via email at CustomerrelationsNA@cookmedical.com.