Parker Waichman LLP

Edwards Lifesciences Warned on Heart Devices

Warned on Heart Devices. 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 […]

Heart Devices

Warned on Heart Devices. 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.

Lifesciences’ experimental Myxo ETlogix 5100 Ring device was at the center of an investigation

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.”

Need Legal Help Regarding Heart Devices?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
About 7 years ago, my sister was in a car accident and was very pleased with the way the firm handled her case. Unforuntately, I was in a car accident and she recommended that I call Parker Waichman. I could not be more happy with the way the case was handled and the outcome. The staff is also very friendly, which was refreshing.
Paul Schaeffer
11 years ago
5 Star Reviews 150
I was recommended to Parker Waichman by Mary Sotomayor and I am very happy with the service. They are all very professional, helpful and knowledgeable . They are also very quick to respond to any of my questions or concerns.
Mary A
5 years ago
5 Star Reviews 150
Parker Waichman are the best. They are always there for you. Theh really care about you. Thank you Jorge peniche and Linda Ingber for helping me
Ramon Mella
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038