Due to an inspection of Edwards Lifesciences in Irvine, Calif., on Sept. 9, 2009, through Sept. 16, 2009, the FDA has sent a warning letter to the company, stating that its annuloplasty ring devices and its pericardial heart valve device are misbranded.
The agency, according to its March 1 letter, determined that Edwards failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803—medical device reporting (MDR) regulation, related to its Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring; IMR ETlogix mitral annuloplasty ring; the Edwards dETlogix annuloplasty ring and the Carpentier-Edwards Perimount pericardial bioprosthesis.
The FDA requires companies to report problems to the agency no later than 30 calendar days after the day that the company receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device that you market may have caused or contributed to a death or serious injury.
The agency said that the following six complaints were not reported within 30 calendar days and are adverse events that resulted in a death or serious injury:
- Complaint HVT001766, Medwatch 2015691-2009-11047;
- Complaint HVT001938, Medwatch 2015691-2009-11233;
- Complaint HVT002195, Medwatch 2015691-2009-11327;
- Complaint HVT001277, Medwatch 2015691-2009-10780;
- Complaint HVT001271, Medwatch 2015691-2009-10630; and
- Complaint HVT001300, Medwatch 2015691-2009-10700.
Edwards acknowledged receiving the warning letter, stating that the “training procedures on the MDR reporting process were corrected during the inspection and discussed with the FDA.”
The company added it does not expect this matter to have any impact on product approvals.