Edwards Lifesciences Warned on Heart DevicesApr 7, 2010 | Parker Waichman LLP
In a letter released yesterday, the U.S. Food and Drug Administration (FDA) said that Edwards Lifesciences Corporation failed to appropriately report six complaints concerning serious problems in patients treated with Edwards’ heart devices, said Reuters. The FDA said, added Reuters, that Edwards Lifesciences did not supply needed information on certain of its 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, quoted Reuters. The complaints were submitted between six and 29 days after the 30-day requirement, said Edwards, which said that its “training procedures on reporting requirements ‘were corrected during the inspection and discussed with the FDA,’" said Reuters The FDA posted the letter at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm207028.htm.
This is not the first time Edwards has experienced problems with its heart devices. We recently wrote that Edwards Lifesciences Corporation issued a recall of CardioVations EndoClamp Aortic Catheter. The FDA has deemed this a Class I recall, its most serious type of recall. The CardioVations EndoClamp Aortic Catheter locks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. According to the recall notice, the balloon catheters may spontaneously rupture during surgery.
We had also written that Edwards Lifesciences’ experimental Myxo ETlogix 5100 Ring device was at the center of an investigation being conducted by Senator Charles Grassley (Republican-Iowa) over his concern that the Myxo Ring was being used in patients even though it was not yet approved by the FDA.
The Myxo ETlogix 5100 Ring, a device that repairs faulty heart valves, was first implanted in a patient in March 2006. In 2008, the FDA has received 10 reports on adverse events related to the Myxo Ring and an investigation was being conducted to determine if the agency received proper notice about the device.
The Grassley investigation was prompted after hearing from Antonitsa Vlahoulis, an Illinois heart patient, and her cardiologist, who said Vlahoulis was implanted with the unapproved device without her consent. According to a prior Reuters.com article, surgeon was Dr. Patrick McCarthy, who Grassley said appears to have invented the device and receives royalty payments from the Edwards Lifescience.
Vlahoulis, who received the device in 2006, told the Chicago Tribune that she would have never consented to receiving an experimental implant. She claimed officials from Northwestern Memorial Hospital and Edwards told her the device was not experimental because it was a modified version of one of the company’s other repair rings, which are approved by the FDA. Vlahoulis later had the Myxo Ring removed because of inflammation, and now needs a heart transplant.
Grassley’s letter said his staff was told by Vlahoulis’ cardiologist that, “the Myxo Ring is not a minor modification because, among other things, the shape of the ring is triangular whereas other annuloplasty rings are oblong.”