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Symmetry Bypass Connector ("Symmetry Sutureless Anastomosis Device")

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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).

St. Jude Symmetry BypassAlthough 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, 185 injuries) associated with devices of this type. A screen shot from that report is reproduced below.

A patient was implanted with an aortic anastomotic device during an off- pump procedure. No difficulties were encountered with loading or deployment of the device. Recovery was good for 40 hours when the patient suddenly lost consciousness after a dramatic drop in blood pressure. CPR was initiated and blood appeared in the drains. At re-operation, the aortic connector was detached from the aorta and the patient died after 10 minutes. The autopsy revealed the cause of death was hemorrhagic shock.

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
Leakage of the bypass at the connector site

These side effects may result in serious health problems including:

Heart attack
Stroke
Respiratory failure
Hemorrhage
Death

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

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