Watchdog group condemns FDA for failure to recall stroke-causing stent

The Food and Drug Administration’s refusal to remove Stryker’s Wingspan Stent System from the market is a reckless disregard for consumer safety, says consumer advocate Public Citizen.

In 2005, the FDA approved the medical device designed to open arteries leading to the brain and prevent stroke. However, a 2011 National Institutes of Health-funded study found patients to be 2.5 times more likely to suffer a stroke or die within 30 days of the device being implanted than those who were treated with blood thinners. The 451-patient study was halted early.

“The Wingspan Stent System was thought to be too dangerous to implant in any more subjects,” says Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, based in Washington D.C. Carome penned a petition to the FDA in December to recall the device. Continued use doesn’t just expose patients to an unacceptable risk of serious harm or death, it guarantees it, he says.

The company continues to support use of the stent to increase the diameter of narrowed arteries in the brain that don’t respond to drug treatment, says Stryker spokeswoman Tamara Cutler.

Today, the FDA convenes an advisory panel to review the safety and effectiveness of the stent from Kalamazoo, Michigan-based Stryker, who acquired the stent when it bought Boston Scientific Corp.