Based on its investigation into complaints that the Zilver® PTX® Drug Eluting Peripheral Stent’s delivery system had separated at the tip of its inner catheter, Cook Medical has initiated a nationwide/global recall of the device, the U.S. Food & Drug Administration (FDA) just announced.
Cook Medical, the manufacturer of the device, received 13 complaints of delivery system tip separation. Two adverse events, including one death, occurred in cases in which a tip separation was reported. Potential adverse events that may take place in cases in which an inner delivery catheter breakage occurs include potential surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, and possible cardiac arrest.
Zilver® PTX® Drug Eluting Peripheral Stent systems were distributed to medical institutions in the United States between December 13, 2012 and April 16, 2013. Cook initiated a voluntary global recall of all sizes, diameters, and lot numbers—catalog number ZIV6*****PTX—of the devices. Consignees are advised to cease using the device, quarantine any inventory, and return the device to the manufacturer for credit.
Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Interventional clinical division said that the recall is specific to the delivery system and does not impact the stent itself. Should a patient be implanted with a Zilver PTX stent and the delivery system was removed safely and intact, that patient is at no risk and is not affected by this recall.
Bare metal versions of Cook Medical’s Zilver Flex® stent use a different delivery system are also not included in this recall.
Cook’s investigation identified an internal component of the delivery system that is used to implant the stent that did not consistently meet established design criteria. Cook also indicated that it conducted an exhaustive quality assessment and audit of the affected components to ensure satisfactory future performance of the delivery system.
The device received FDA premarket application approval in the U.S. in November 2012 and received CE Mark clearance in August 2009. The device is approved for sale in 54 countries including Japan, Australia, and Brazil and is manufactured at Cook’s facility in Limerick, Ireland.
Cook Medical Customer Relations may be reached, toll-free, at 1.800.457.4500 or at 1.812.339.2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m., Eastern Standard Time, or by email to CustomerRelationsNA@cookmedical.com.
Adverse events or quality problems experienced with the use of this product may also be reported to the FDA online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. There, a form is available to fax or mail. The FDA may also be reached by telephone at 1.800.FDA.1088.