Baxter Unit Must Keep Track of Heart Valves : * Health: Edwards CVS Division has made some defective valves. Efforts to trace past recipients began last November.

A Baxter Healthcare Corp. unit that has made some faulty heart valves in the past says new federal regulations mean that the company must begin keeping track of patients who will receive its valves in the future.

Baxter’s Edwards CVS division, based in Irvine, has known since at least 1988 that some of its valves were breaking inside patients’ hearts.

The company says 26 failures of two discontinued valve models have occurred and have been linked with eight deaths.

But it wasn’t until last November that the company began tracking down the 20,000 people who received the valves between 1982 and 1988, when the models were discontinued.

“This sort of thing had only been done” once before, said Roberta Hines, manager of regulatory affairs at Edwards, in explaining why the patient notification program began only last year. “Until then, all our efforts had been directed at the surgeons, and they were to notify the patients.”

The new federal rules were prompted in part by the far bigger and better-known case of another Irvine company, Shiley Inc., a unit of the large New York drug company Pfizer Inc. Shiley manufactured a heart valve in the 1970s and 1980s that has been blamed for 265 deaths so far.

The FDA finally persuaded Shiley to begin tracking down the 55,000 people who had been implanted with its valves. Such critics as Dr. Sidney Wolfe of the Ralph Nader group Public Citizen said that Shiley dragged its feet and that the FDA was too timid.

Even though Shiley already had some names of patients and the hospitals where they had received their valves, finding current addresses for them is said to be a time-consuming and expensive process.

One lawyer who has sued both companies on behalf of heart-valve recipients says the firms will probably never locate all the patients.

“The probability of finding all of these people more than five years after the valves were implanted is practically nil,” said Edward H. Kellogg Jr. of Atlanta. “Especially the foreign ones.”

The two discontinued models of Edwards valves--the Edwards-Duromedics Bileaflet Valve models 3160 and 9120--were implanted in 1,500 Americans and 18,500 foreign citizens in the mid-1980s.

Edwards says it has managed to find 70% of the American patients since November. But the foreign residents, it concedes, will be much tougher to locate.

“For any kind of tracking like this, it’s going to be very costly and burdensome,” said Hines, the company’s manager of regulatory affairs. “But it’s going to be even more difficult in foreign countries.

“For one, the patient confidentiality laws in some countries will make it extremely hard to retrieve information.”

When patients are located, they are instructed to carry a card with them at all times so that if they appear to suffer a heart attack, medics will know that it could be a broken valve.

The valves are coated with carbon and have two half-moon-shaped leaflets attached with a hinge that regulate the flow of blood to the heart. It is these leaflets that have broken off in the 26 cases so far.

Kellogg, the lawyer, represented a foreign family in what he says was the first reported case of a Baxter Edwards valve failure: A 26-year-old Pakistani woman living in London who died in 1985.

Kellogg had sued Baxter in 1987 in Austin, Tex., where Hemex Scientific--the actual maker of the valve--is based. Edwards had bought Hemex the year before for $50 million.

The company maintained that the prominent British surgeon who operated on the woman had mishandled the valve during the operation. The company also asked that the suit be thrown out on grounds that foreigners must sue in their own courts.

When the Texas courts disagreed, Kellogg said, the company settled before trial in 1990 for an undisclosed amount that the lawyer would only say was “sizable.”

The new federal regulations on tracking patients--required by 1990 amendments to the Safe Medical Device Act--take effect May 28.

The regulations cover not only heart valves but other types of devices permanently inserted in the body, such as breast implants and pacemakers.

The regulations affect 35 types of devices made by 370 manufacturers, the FDA said. The rules say a manufacturer must now be able to identify patients and their locations and be able to report them to the FDA within three working days.

Baxter Healthcare Corp. is the main unit of Baxter International Inc. in Deerfield, Ill., a Fortune 500 company and the world’s leading maker of health care products such as surgical instruments.

Baxter reported profits of $591 million on sales of $8.9 billion last year.