Edwards Stops Making Its Primary Heart Valve Line Following 6 Deaths

Edwards CVS, an Irvine-based division of Baxter International, has stopped manufacturing its primary line of mechanical heart valves following reports of six deaths linked to malfunctions of the devices.

According to the U.S. Food and Drug Administration, about 20,000 of the valves have been implanted in patients in the United States and overseas since 1982.

Physicians have been urged to closely monitor recipients rather than remove the valves already in place, Walter Schneggenburger, head of the FDA’s Santa Ana office, said Monday.

In addition, Edwards has asked physicians, hospitals and dealers to return to the company an estimated 6,000 valves that have not yet been installed.

Edwards is one of the nation’s leading manufacturers of both mechanical and organic tissue heart valves. Baxter, its parent company, is headquartered in Deerfield, Ill.

The heart valves in question were marketed as Edwards-Duromedics Aortic Bileaflet Valve Model 3160 and Mitral Bileaflet Valve Model 9120. They are of the carbon bileaflet variety, which has become the mechanical valve of preference among heart surgeons in recent years, industry experts said.

So far, the FDA has received reports of 12 valve malfunctions, of which six resulted in deaths. In each instance, gate-like “leaflets” regulating the flow of blood through the valves broke loose, Schneggenburger said.

The company said it decided to stop manufacturing the valves until the cause of the malfunctions can be determined, including whether they are related to design or manufacturing problems.

“We have notified our entire physician base nationwide” about the valve malfunctions, said Baxter spokesman Les Jacobson.

“Twelve out of 20,000 is a very small number,” Jacobson said. “But it was disturbing enough for us to decide to do the prudent thing.”

The FDA is not recommending removal of the valves because medical experts have told the agency that removing the valves could pose a greater health risk to recipients than leaving them in place, Schneggenburger said.

Last year, sales of Edwards carbon bileaflet valves generated $12 million in sales for Baxter, a major health product company with $6 billion in total revenues.

According to FDA officials, Edwards suspended all marketing of the carbon bileaflet valves on May 16 and stopped manufacturing shortly thereafter.

Schneggenburger said the FDA is following up to make sure that all hospitals that purchased the valves and physicians who reported using them have received the recall notices and taken appropriate action.

Jacobson said all malfunctions reported to date have involved heart valves sold overseas. No pattern has emerged regarding the kind of patients who have experienced heart valve breakages, he said. Those reported so far have included men, women and children whose implants had been in place anywhere from 5 to 36 months.

Most Recipients Overseas

Most of the 20,000 patients who have received the valves are overseas because the valves in question have been approved for marketing in the United States only since May, 1987.

According to the FDA, the faulty valves were manufactured at plants in Austin, Tex., and in Shelkshine, Scotland, from 1983 through August, 1986, by Hemex Scientific, which was acquired by Baxter Travenol Laboratories Inc., now called Baxter International, in December, 1986.

After the acquisition, Baxter incorporated some design changes in the valves, Jacobson said. It is not known if those changes made the valves less prone to breakage, he said.

Industry observers said the $50-million Hemex acquisition was important to Baxter because its own existing line of “cage-ball” mechanical heart valves was becoming outmoded and losing market share to carbon bileaflet valves, which were believed to impede blood flow to a lesser extent.

“They really needed a carbon bileaflet valve to compete in the mechanical heart valve market,” said Pieter Halter, a former director of sales and marketing for Edwards. Halter, who is now a health care specialist for a Southern California venture capital firm, estimates that carbon bileaflet valves constitute 90% of the mechanical heart valve market.

Competing carbon bileaflet valves are sold by Edwards’ chief heart valve competitors, St. Jude Medical of St. Paul, Minn., and Medtronic Inc. of Minneapolis, Minn.

Market Opportunity

Halter said Edwards wanted a new mechanical heart valve to take advantage of a market opportunity that materialized when Shiley Inc., an Irvine-based subsidiary of Pfizer Inc., was beset with lawsuits and recalls resulting from malfunctions of one of its most popular mechanical valve models.

Jacobson said Edwards was about to transfer production of carbon bileaflet valves from Austin to Irvine when problems with its own valves became apparent.

Jacobson acknowledged that while Edwards has maintained industry leadership in tissue heart valves, it had counted on the Hemex heart valve product line to boost it to greater prominence in the mechanical heart valve market.

“The mechanical valve market has been growing and this represents our major thrust in it,” he said. He called the voluntary recall “a setback, but hopefully a temporary one.”