Investigation and potential lawsuit against St. Jude Medical for the design, sale and manufacture of defective aortic connector devices ("Symmetry Bypass System Aortic Connectors").
The Symmetry Bypass System Aortic Connector is implanted during coronary artery bypass graft surgery and allows thoracic surgeons to attach saphenous (leg) vein grafts to the aorta without sutures and without clamping the aorta during the procedure. The St. Jude Medical device is one part of a system comprised of an aortic cutter ceepo.co.uk
, a delivery system and the connector.
After an abbreviated approval process allowed by law, the U.S. Food and Drug Administration approved the St. Jude Medical device in 2001, for use in the United States. There have been thousands of the devices implanted during coronary bypass surgery, mostly in "off pump" or "beating heart" procedures where surgeons do not place the patient on the heart lung machine. However, it became clear that patients with the aortic connectors in place have a higher rate of graft narrowing, leakage, failed deployment, and occlusion (closing) than do patients without aortic connectors. The FDA began receiving reports of failure.
Many of the symmetry bypass aortic connector patients had to undergo a second, repeat coronary bypass procedure to redo the graft and remove the aortic connector device. Many suffered adverse medical events, such as heart attacks, respiratory failure, possibly even death. Despite adverse reports, St. Jude Medical neither conducted clinical trials or testing of a larger segment of the post-cardiac bypass population, nor have they made any alterations in design or manufacture that would lessen the great danger the aortic connector poses to implant patients. Additionally, St. Jude Medical has not contacted the medical community to emphasize the importance of regular monitoring and testing of implant patients.
The company continues to market and sell the symmetry bypass system aortic connectors today to the lucrative cardiac surgery market.