Irvine Firm Quietly Recalls Mechanical Heart Valves

An Irvine firm, whose faulty mechanical heart valves have caused more than 100 patient deaths worldwide and been recalled four times, has quietly recalled several thousand more heart valves in its other major product line, The Times has learned.

The latest recall comes after six complaints from cardiac surgeons around the country who had to discard damaged heart valves in the middle of heart operations, Robert Curtis, president of Shiley Inc., confirmed in an interview.

Normally, the artificial valves should not have folds in the leaflets that control blood flow. But the surgeons discovered that the leaflets of some valves had been folded.

“The chances that one of these folded valves was implanted in a patient is extremely small,” Curtis said.

The latest recall covers about 2,000 unimplanted tissue heart valves manufactured between May, 1984, and January, 1986, and distributed in the United States, as well as additional valves sold abroad. Shiley had no estimate of how many of these recalled valves may be damaged.

During the 22-month period, surgeons implanted about 4,000 of the valves, called the standard model of the “Ionescu-Shiley pericardial xenograft.” The valves are made from preserved animal heart tissue.

The voluntary recall was announced in a Feb. 27 letter to hospital administrators and cardiac surgeons throughout the country.

It follows recalls in 1980, 1982, 1983 and 1985 of some of Shiley’s mechanical heart valves because of serious malfunctions that often led to patient deaths. No other heart valve manufacturer has had a comparable problem with faulty valves.

Hospitals were asked to “quarantine” the valves until they could be exchanged, according to the recall letter. Shiley said there was no danger in using one of the quarantined valves in an emergency, provided that no folded leaflets were found.

The U.S. Food and Drug Administration was simultaneously informed of the recall and is still analyzing the situation, an official said Friday.

Both the FDA and Shiley said they had no reports of unusual or increased problems for patients related to the valves manufactured during the recall period that have been implanted.

“Our consulting cardiologists and surgeons have recommended essentially no difference in patient management” Curtis said, referring to those who have received such valves. “The surgery panel recommended against notifying patients but we are still reviewing this.”

‘Essentially No Different’

Curtis said laboratory tests showed the folded valves to be “essentially no different” from the undamaged valves. But he acknowledged that there is “no conclusive way” to determine if problems may develop in patients later.

Shiley, the world’s largest manufacturer of artificial heart valves, plans to inspect all the recalled valves for folds and then reship the normal ones, Curtis said.

The Ionescu-Shiley valve was first used in patients in 1971 and has been marketed by Shiley since 1976. The valve is the second most widely used tissue heart valve in the world, according to the newsletter Biomedical Business International.

The recall letter, signed by Curtis, blames deficiencies in the “final packing process” for the folds. “Shiley implemented improved manufacturing and quality procedures . . . to correct this condition,” the letter states.