The FDA has cited Edwards Lifesciences for failing to report six serious side effects in patients with the company's 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 agency says in its letter.
The reporting lapse was discovered after a 2009 FDA inspection of the Irvine, California-based plant. Some of the complaints were six days overdue, while others weren't submitted until almost a month after the reporting window was closed. According to the company, the reporting issues were fixed during the inspection, and Edwards does not expect this matter to have any impact on product approvals.
A Goldman Sachs analyst tells Reuters that the warning letter shouldn't have any major impact on the company, considering it was a paperwork error and not related to any suspension of sales or product recall.
- see Edwards' statement
- here's the Reuters report