|The FDA has assigned a Class I tag to Cook Medical's Zilver PTX recall.--Courtesy of Cook Medical|
The FDA has affixed its most serious warning to Cook Medical's recall of the Zilver PTX stent, warning that problems with the device's delivery catheter could lead to thrombosis, amputation or death.
Cook recalled the device in April, just a few months after winning FDA approval. Cook said the problem stems from an internal component of the delivery catheter, causing a small number of the devices to separate during implantations and put patients at risk. The stent itself is perfectly safe, according to the company, so patients already implanted with the device are not affected by the recall.
The company said it has received 13 reports of delivery system failures, resulting in two adverse events. One patient died during a Zilver PTX procedure, but Cook said it has no evidence that the delivery system played a role.
The FDA ruled the recall a Class I, a designation the agency saves for malfunctions that carry risks of serious adverse events including death, asking customers to report any problems with Zilver PTX through the online MedWatch system.
Cook said it has identified the flaw in the delivery system and has amended its Zilver PTX manufacturing process to avoid future problems.
The global recall puts a damper on Cook's excitement over Zilver PTX, which became the first drug-eluting stent cleared to treat peripheral artery disease in the U.S. when it won FDA approval in November. Cook has said it believes the stent could revolutionize PAD treatment the way drug-eluting stents did for coronary artery disease, but the early-stage recall will undoubtedly push back Cook's plans to launch more sizes of Zilver PTX.
- read the FDA's notice
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