Deaths Spur Recall, Manufacturing Halt For Mechanical Heart Valves
Deaths Spur Recall, Manufacturing Halt For Mechanical Heart Valves .....................CORRECTIVE OF JUNE 23, 1988 FOLLOWS....................
IRVINE, Calif. (AP) _ The Associated Press reported erroneously on June 21 that a spokesman for Baxter International said the company’s Edwards Division subsidiary recalled 6,000 unused mechanical heart valves.
The statement should have been attributed to the U.S. Food and Drug Administration.
IRVINE, Calif. (AP) _ A subsidiary of Baxter International has stopped making two mechanical heart valves and recalled 6,000 unused devices after malfunctions caused six deaths, a company spokesman said.
Valve malfunctions in 12 patients were reported to the U.S. Food and Drug Administration, and six of the malfunctions were fatal, Walter Schneggenburger, who heads the FDA’s Santa Ana office, said Monday.
Baxter International spokesman Les Jacobson says the company doesn’t know how many of the valves will be returned as a result of the recall, but that the actual number will be closer to 3,000.
The recall was spurred by malfunctions that caused six deaths among an estimated 20,000 patients who had the valves implanted, according to the FDA. The recalled valves were marketed as Edwards Duromedics Aortic Bileaflet Valve Model 3160 and Mitral Bileaflet Valve Model 9120. (2047EDT) .............................................................................
The valves had been implanted in 20,000 patients, most overseas, and all of the malfunctions occurred overseas. The valves were approved for sale in the United States only in May 1987.
″Twelve malfunctions out of 20,000 is a very small number, but it was disturbing enough for us to decide to do the prudent thing″ by halting manufacture of the two models, said Les Jacobson, spokesman for Deerfield, Ill.-based Baxter. The company’s Irvine-based Edwards Division makes the valves.
Doctors have been urged to monitor closely patients who are using the valves rather than have them removed, Schneggenburger said.
The recalled mechanical valves were marketed as Edwards Duromedics Aortic Bileaflet Valve Model 3160 and Mitral Bileaflet Valve Model 9120.
The malfunctions occurred when gatelike ″leaflets″ regulating the flow of blood through the valves broke loose, Schneggenburger said.
The Edwards Division is one of the leading U.S. manufacturers of mechanical heart valve replacements and valves made of organic tissue.
The recalled valves are known as carbon bileaflet valves. Heart surgeons have preferred them over other types of mechanical valves in recent years, with an estimated 90 percent of mechanical valves of the carbon bileaflet variety, said Pieter Halter, Edwards’ former sales and marketing director.
Jacobson said the company stopped manufacturing the valves shortly after it suspended their marketing May 16, and won’t make more of them until it can learn why they failed.
The failed valves were made from 1983 through August 1986 by Hemex Scientific - which was acquired by Baxter in December 1986 - at factories in Austin, Texas, and Shelkshine, Scotland.
Jacobson said design of the valves was changed after the acquisition, but it isn’t yet know if those valves are less prone to failure.
Last year, Edwards’ carbon bileaflet valves generated $12 million in sales for Baxter, a health products company with $6 billion in annual revenues.