Cook Medical's Zilver PTX Receives Class I Recall Status

Following reports that Cook Medical's Zilver PTX drug-eluting stent could separate from delivery catheters during implantation, the device received Class I recall status from the FDA. The company recalled the device in April due to an issue with its delivery catheter. Under some conditions, the delivery catheter could put a patient at an increased risk of amputation, thrombosis or death.Only a few months after gaining FDA approval, Cook Medical noted an issue with the Zilver PTX's delivery catheter. In particular, an internal component in the delivery catheter could cause the device to separate during implantation. Since the stent itself is safe, the recall doesn't impact patients who have already received the Zilver PTX stent.As of now, there have been 13 verified reports of delivery system failure. Two of these reports led to adverse events. While one patient died during implantation of the Zilver PTX, Cook Medical states there is no evidence that the patient's death was caused by the flawed delivery system.Cook Medical announced that it has successfully identified the delivery system flaw and has made changes to its manufacturing processes to avoid the issue in the future.Less than a year ago, the Zilver PTX was touted as the first FDA-approved drug-eluting stent designed for the treatment of peripheral artery disease. While the recall dampens excitement for the device, Cook Medical still believes that its new stent could revolutionize PAD treatment in the U.S. The release of the Zilver PTX in different sizes has been delayed. Related Content: This Month in Medical Device Recalls: May EditionCook Medical Recalls Zilver PTX Stent Following Patient DeathFDA Grants PMA for Cook Medical's Zilver PTX Stent