The FDA last month accused Cook Medical of selling an unapproved device in the U.S., saying changes made to Cook Vascular’s Evolution RL cardiac lead extraction device require the medical device company to file a new clearance application with the watchdog agency.
"The United States Food & Drug Administration (FDA) has learned that your firm is marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets in the United States without marketing clearance or approval," according to the April 25 letter, which the FDA posted online May 5.
The FDA said a review of Cook’s website and a promotional brochure for the Evolution Shortie RL, an iteration of the Evolution RL device that won 510(k) clearance in 2006, "provides evidence that the device has undergone design changes including what appears to be an extension to the Evolution line and material changes to the sheath since the device was cleared."
"As described in the promotional materials on your firm’s website and in a product brochure, these changes represent major changes or modifications to the intended use of your firm’s device," according to the warning letter.
The changes include the addition of a birotational sheath, an updated handling system and larger sheath sizes, the agency said.
"A larger size for this sheath may incur new risk factors, which would need to be evaluated and mitigated. In addition, your firm is offering what appears to be a new device system, the Evolution Shortie RL Dilator Sheath Set, which claims to be designed specifically for vessel entry. These claims will need to be substantiated and evaluated in a new 510(k)," according to the letter. "Our office requests that Cook Vascular immediately cease activities that result in the misbranding or adulteration of the Cook Evolution Mechanical Dilator Sheath Set, such as the commercial distribution of the devices for the uses discussed above."
Cook Vascular president Louis Goode, in a statement to MassDevice.com, said the company is already moving to comply with the FDA’s findings.
"We appreciate the FDA’s findings and questions about our internal process regarding when certain regulatory filings are required. We have already responded, adjusted our processes, and will continue to fully cooperate with the FDA until the agency is satisfied," Goode said.
A check of Cook Medical’s website for the Evolution Shortie RL today showed a prominently displayed warning reading, "This product is not available in the United States."
The FDA warning letter coincides with Cook Medical’s celebration of the 25th anniversary of the invention of cardiac lead extraction technology.