Edwards Lifesciences Corp., the Irvine-based heart valve maker, received a warning letter from the Food and Drug Administration concerning some of its devices.
The company failed to properly report six complaints about serious problems in patients treated with the company’s devices and didn’t provide required information, according to the letter.
“Six complaints were not reported within 30 calendar days and are adverse events that resulted in a death or serious injury,” the FDA told Edwards in the letter, which was dated March 1 and made public Tuesday.
The devices in question are certain types of annuloplasty rings, which are used to fight disorders where blood leaks backward, and a replacement heart valve.
The FDA said in the letter that Edwards had 15 days from the date of receipt to outline specific steps to correct the problem and share those with regulators.
Edwards said in a statement that it corrected its training procedures on medical device reporting during a regulatory inspection and discussed those changes with the FDA. The device maker said that it didn’t expect the matter to have impact on product approvals.
Edwards’ shares were down about 2% with a market value of $5.7 billion in early afternoon New York trading.
