April 6, 2010 / 2:23 PM / 10 years ago

FDA warns Edwards on heart device complaints

WASHINGTON (Reuters) - Edwards Lifesciences Corp failed to properly report six complaints about serious problems in patients treated with Edwards heart devices, U.S. regulators said in a letter released on Tuesday.

The Food and Drug Administration said Edwards did not provide required information about certain types of annuloplasty ring devices and a pericardial heart valve device.

“Six complaints were not reported within 30 calendar days and are adverse events that resulted in a death or serious injury,” the FDA said in a March 1 letter to the company.

Shares of the company fell 1 percent to $102.07 in afternoon trading on the New York Stock Exchange.

Edwards said in a statement the letter resulted from a September 2009 FDA inspection of the company’s Irvine, California, facility.

The six complaints were submitted between six and 29 days beyond the 30-day requirement, the company said. Training procedures on reporting requirements “were corrected during the inspection and discussed with the FDA,” Edwards said.

The company said it “does not expect this matter to have any impact on product approvals.”

The FDA sends dozens of warning letters to companies each year. Most issues raised in the letters are resolved without further action, but some cases can lead to product seizures or other penalties.

Goldman Sachs analyst David Roman said the products referenced in the letter represented about $40 million to $50 million, or 3 percent of total corporate sales. “We do not see any of this revenue at risk, given that the letter will not result in a suspension of sales or a recall of any products,” Roman said in a research note.

He said the FDA letter was “related to a paperwork issue that will not prevent the company from shipping product.”

Wells Fargo Securities analyst Larry Biegelsen said the problems in the letter to Edwards were “easily addressable.”

“We do not view this warning letter as concerning,” Biegelsen said in a research note.

The FDA posted the letter here

Reporting by Lisa Richwine, editing by Gerald E. McCormick, Steve Orlofsky, Dave Zimmerman

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