Inspections, Compliance, Enforcement, and Criminal Investigations
Edwards Lifesciences, LLC
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20993
MAR 1 2010
VIA FEDERAL EXPRESS
Michael A. Mussallem
Chairman and CEO
Edwards Lifesciences, LLC
1 Edwards Way
Irvine, CA 92614
Dear Mr. Mussallem:
During an inspection of your firm located in Irvine, California on September 9, 2009 through September 16, 2009, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the 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. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that your annuloplasty ring devices and your pericardial heart valve device are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm 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. Significant deviations include, but are not limited to, the following:
Failure to report to us no later than 30 calendar days after the day that you receive or otherwise become 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, as required by 21 CFR Sec. 803.50(a)(1).
For example: 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
• Complaint HVT001300, Medwatch 2015691-2009-10700
You should take prompt action to correct the violation addressed in this letter. Failure to promptly correct this violation may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include but are not limited to seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Pleas notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violation, including an explanation of how you plan to prevent this violation, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Michelle Noonan-Smith Cling Branch Chief 10903 New Hampshire Avenue WO66 Room 3652, Silver Spring MD 20993. If you have any questions about the content of this letter please contact: Shevon Johnson at (301) 796-5584 or by facsimile at (301) 847-8138.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation at our facility. It is our responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation noted in this letter and in the Inspectional Observations Form FDA 483 (FDA 483) issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation and take prompt actions to correct the violation and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and