|Courtesy of Cook Medical|
Cook Medical has launched a global recall for its banner Zilver PTX stent, warning that a small number of the devices broke from their delivery catheters during implantation.
The issue stems from the delivery system, not the stent itself, Cook said, meaning patients already implanted with the device are not at any risk. The company received a total of 13 reports of delivery system failure, resulting in two adverse events. One patient died during a Zilver PTX procedure, but Cook said there is no evidence that the delivery system played a role in that.
Cook has identified the internal component causing the problem, and the company said it has amended its manufacturing process to avoid making the same mistake. The FDA is aware of the recall, Cook said, but the agency has yet to issue a class designation.
Zilver PTX won FDA approval back in December, making it the first drug-eluting stent cleared to treat peripheral artery disease in the U.S. At the time, Cook predicted the device could revolutionize PAD treatment the way drug-eluting stents did for coronary artery disease, but the global recall is certain to push back Cook's plans to roll out more sizes of the device throughout the year.
The stent received a CE mark back in 2009 and has been on the market in 54 countries overseas ever since. Cook launched the device in the U.S. in December and said it had shipped stents to 84 medical institutions since then.
- read Cook's announcement
Special Report: Cook Medical's Zilver PTX - Top 10 device and diagnostic FDA approvals of 2012
Correction: An earlier verison of this story misstated the relationship between Zilver PTX and the death of a patient. Cook Medical said there is no evidence the stenting procedure caused the patient's death. We regret the error.