On 24 April 2013, according to a press release, based on its investigation into complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver PTX drug-eluting peripheral stent.
According to the release, Cook received 13 complaints of delivery system tip separation with an occurrence rate of 0.043%, according to a press release. Two adverse events, including one death, occurred in cases where a tip separation was reported.
Cook advised that potential adverse events that may occur in cases where inner delivery catheter breakage occurs include: possible surgery to remove the catheter tip; vascular occlusion due to an unretrieved catheter tip; thrombosis; amputation; and possible cardiac arrest.
These devices were distributed to medical institutions in the USA between 13 December 2012 and 16 April 2013. Cook initiated a voluntary global recall of all sizes, diameters and lot numbers (Catalogue number ZIV6*****PTX). The advice given in the press release was for Consignees to stop using the device, quarantine any inventory and return it for credit.
The recall, said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Interventional clinical division, is specific to the delivery system, not the stent itself. If a patient has had a Zilver PTX stent implanted 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 that is not included in this recall.
Cook’s investigation identified an internal component of the delivery system used to implant the stent that did not consistently meet established design criteria. Cook has conducted an exhaustive quality assessment and audit of the affected components to ensure satisfactory performance of the delivery system in the future.
The device received FDA premarket application approval in the USA in November 2012. It received CE mark clearance in August 2009 and is approved for sale in 54 countries including Japan, Australia and Brazil.
“We initiated a voluntary global recall because, while the occurrence of the component separation was very low, we felt the risk to patients required us to act with an abundance of caution,” said Lyles. The USA Food and Drug Administration (FDA) was been made aware of this recall.
Please report any adverse event to Cook Medical Customer Relations (800) 457-4500 or 1-812-339-2235, Monday to Friday between 7:30 am and 5:00 pm, Eastern Time or email at [email protected].
Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online athttp://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or call FDA 1-800-FDA-1088.