Shiley to Stop Making Heart Valve Devices

Shiley Inc. of Irvine is suspending production of all remaining models of a heart valve that is blamed for at least 125 deaths and recalling existing inventories, according to a Food and Drug Administration official.

In a letter mailed last week, Shiley told physicians that it would suspend production of its Bjork-Shiley 60 Degree Convexo-Concave heart valves, said Mark Barnett, assistant director of education at the FDA’s Center for Devices and Radiological Health.

Shiley officials could not be reached for comment.

Fractures in struts used to hold an out-flow valve disc prompted several recalls of the large version of the valves, which were removed from the market late last year after several failures.

Death Rates

The mechanical valve, approved in 1979, was implanted in victims of rheumatic heart disease, or patients whose natural heart valves have calcified. According to the FDA, strut fractures began to occur after the valves were marketed. A fracture resulted in the user’s death about two-thirds of the time.

While the large valves had a strut fracture rate of 13 per 10,000 a year, the fracture rate for the small valves was only 2 per 10,000 per year, according to the FDA. Despite the relatively low failure rate for the small sizes, “negative publicity” adversely affected sales and the small valves were “no longer economically viable,” Shiley said in its letter.

The decision to stop production came less than three weeks before an FDA advisory panel was scheduled to review new data about the valve, Barnett said Friday. However, the meeting now is a “moot point” and has been canceled, he said.