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Current Cases / St. Jude Symmetry Bypass

St. Jude Symmetry Bypass Connector: Injuries and Deaths: Lawsuit Pending Filed*

*Allegations from complaint: "The use of this device has led to severe and disabling medical conditions resulting from collapse and scarring of the graft as a result of the implanted Aortic Connector . . . ."

The St. Jude Symmetry Bypass Connector ("Symmetry Sutureless Anastomosis Device") is a nitinol, star-shaped device that was designed to facilitate off-pump coronary artery bypass graft surgery (CABG).

Although the "Symmetry Sutureless Anastomosis Device" is approved for clinical use in Europe and the U.S., its short- and long-term safety and efficacy are not established. Researchers report complications with the Symmetry device and state that:

"Prospective randomized clinical trials are needed to assess the clinical safety and efficacy of this device [Symmetry Bypass Connector]. Pending such studies, consideration should be given in limiting its use to cases of unacceptably high risk of stroke during aortic cross clamping. Dual antiplatelet agents, evaluation for ischemia, and close follow-up are warranted in patients who have already received the device."

See Severe ostial saphenous vein graft disease leading to acute coronary syndromes following proximal aorto-saphenous anastomoses with the symmetry bypass connector device - Is it a suture device or a ''Stent''? J Am Coll Cardiol, 2004;43(1):133-139.

According to a report presented at the FDA, there have been at least 213 adverse events (23 deaths and 185 injuries) associated with devices of this type. A screen shot from that report is reproduced below.

Published reports indicate that the use of this device may result in complications including: Occlusion, neointimal hyperplasia, stenosis—blockage or partial blockage of the vein graft; Blood clot; and Leakage of the bypass at the connector site. These side effects may result in serious health problems including: Heart attack, Stroke, Respiratory failure, Hemorrhage, and Death.

If you have been implanted with a Symmetry Bypass Connector (aka "Symmetry Sutureless Anastomosis Device"), please contact Audet & Partners immediately to protect your rights.

Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred. Audet & Partners represents individuals, governmental entities, small businesses and institutional shareholders in product liability, tort, negligence, consumer, construction defect, investment fraud, securities, insider trading, antitrust, environmental, whistle blower, aviation and employment cases. In recognition of their outstanding abilities and commitment to the legal profession over the years, the firm and its members have served as Court-appointed Plaintiffs’ Counsel in dozens of federal and state cases throughout the United States.