Cook Medical is recalling its Zilver PTX Drug Eluting Peripheral Stent after receiving complaints about delivery system tip separation. Two adverse events, including one death, occurred in cases where a tip separation was reported.
Cook initiated a voluntary global recall of all sizes, diameters and lot numbers. The recall is specific to the delivery system, not the stent itself, according to Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Interventional clinical division.
The company reported receiving 13 complaints that the delivery system of the device had separated at the tip of the inner catheter. Cook’s investigation identified an internal component of the delivery system used to implant the stent that did not consistently meet established design criteria.
Potential adverse events include possible surgery to remove the catheter tip; vascular occlusion due to an unretrieved catheter tip; thrombosis; amputation; and possible cardiac arrest. Those with the device should stop using it, quarantine any inventory and return it for credit, Cook Medical instructed.
Patients with Zilver PTX stents implanted in whom the delivery system was removed safely and intact are at no risk and are not affected by this recall. Bare metal versions of Cook Medical’s Zilver Flex stent use a different delivery system that is not included in this recall, the company said.
The device received FDA premarket application approval in November 2012 and CE Mark clearance in August 2009.
Adverse events can be reported to Cook Medical or to the FDA via MedWatch.