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Defective Medical Device

Symmetry Bypass Aortic Connector Lawyer

In May 2001, the FDA approved a St. Jude Medical cardiovascular device that was supposed to revolutionize coronary bypass surgery. The Symmetry™ Bypass Connector was intended to make the vein graft process quicker, more precise and standardized to reduce the risk of stroke. Instead, in the years since the U.S. introduction of the device, hundreds of reports to the FDA and evidence revealed by concerned doctors have linked the Symmetry aorta connector to blockages, blood clots, heart attack and death.

What is the Symmetry Bypass Connector?
St. Jude Medical’s Symmetry Bypass Connector is a device that allows vein grafts to be attached to the aorta almost instantly and without sutures during a coronary artery bypass graft (CABG) procedure. The device is a star-shaped network of nitinol wires that attaches the vein graft to the aorta automatically during the heart bypass surgery procedure called “off-pump,” a technique that allows the heart to continue beating during the operation.

The perceived advantages of the Symmetry bypass device include:

The short time period: suturing at the vein graft to the aorta can take from 3 to 5 minutes, and attachment with the Symmetry device takes about 10 seconds.

The “off-pump” procedure: operating on the heart without putting the patient on the heart-lung machine is thought to reduce the likelihood of complications. The device is supposed to be more precise than sutures when deployed during the “off-pump” procedure.

No clamping of the aorta: thought to be the most important benefit, when the Symmetry device is used, there is no need to clamp off the aorta. During conventional bypass surgery, the aorta is clamped off for stabilization during the vein attachment raising the risk of plaque in the aorta breaking off and being released into the bloodstream, thereby causing a stroke.

Who is affected?
As of November 2002, over 30,000 Symmetry devices had been implanted worldwide. It is estimated that at least 20,000 more of the devices have been implanted since that time. Only doctors specifically trained by St. Jude Medical were authorized to perform the bypass surgery using the Symmetry aortic connector device. Patients should have been advised of a new “sutureless” bypass surgery technique recommended by the doctor, and, at a cost of about $600 per usage, one device per bypass could have been used.

What are the risks?
In a March 2004 FDA panel that discussed circulatory system devices, the performance of automatic bypass connectors, including the Symmetry device, was evaluated. According to reports of adverse events submitted to the Medical Device Reporting system and MedWatch, 213 adverse events occurred. Of these events, 23 were deaths and 185 were injuries; only 5 device malfunctions were included in this total. Most of the health problems associated with the Symmetry device surface within 6 months and are detectable with an angiogram; however, many patients report no significant symptoms and receive follow-up tests only if problems are suspected. 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
  

What is being done to protect consumers?
In a report published in the January 2004 issue of the Journal of the American College of Cardiology, a group of California cardiologists reported findings from their experience with the Symmetry device. During their study five out of a total of 121 patients experienced serious and life-threatening blockages after the Symmetry device was used in their bypass surgeries. Citing other studies and their own research, the doctors surmised that the blockages and other serious complications associated with the Symmetry device were due to neointimal hyperplasia, or an abnormal buildup of cellular tissues around the device. They recommended that, pending serious clinical trials, the Symmetry device should only be used in cases where there exists an unacceptably high risk of stroke during aortic cross clamping.

According to evidence presented by doctors in the March 2004 FDA panel, other experts agree with these findings. One doctor team reported that 80% of their patients receiving the Symmetry device experienced serious blockages and subsequently petitioned the doctors and hospitals in their area to stop using the device. Another doctor and researcher that presented information to the panel had conducted a trial using the Symmetry device that had to be halted because of the unnecessary risk the aortic connector was presenting to patients. As a result of that FDA panel, the FDA determined that serious clinical trials assessing the effectiveness and safety of the Symmetry aortic connector and related devices should be conducted.

What should I do if I received a Symmetry Bypass Connector?
If a Symmetry aortic connector device was used during your bypass surgery, you should request an angiogram to determine if there are problems with the bypass, especially at the connector site. And remember that chest pain or other related symptoms are not necessarily present in the event of a problem; you may be relatively symptom free and still be experiencing a blockage, bypass leakage, or worse because of the device.

If you or someone you love has experienced any adverse event related to the use of a Symmetry aortic connector, we want to help. Contact our lawyers today for an immediate and confidential evaluation of your case.


“Severe Ostial Saphenous Vein Graft Disease Leading to Acute Coronary Syndromes Following Proximal Aorto-Saphenous Anastomoses With the Symmetry Bypass Connector Device,” Journal of the American College of Cardiology, January 2004.

FDA Circulatory System Devices Panel, March 18, 2004.

Symmetry™ Bypass Connector is a trademark of St. Jude Medical, Inc. and is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by or associated with St. Jude Medical, Inc., the FDA, or the Journal of the American College of Cardiology.

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If you or someone you love has been injured as the result of a dangerous product, contact a Pennsylvania personal injury lawyer at SchmidtKramer. Our office is located in Harrisburg and we have successfully advocated for clients throughout Pennsylvania, including Camp Hill, Carlisle, Chambersburg, Harrisburg, Juniata, Lancaster, Lebanon, Lewisburg, Lewistown, Mechanicsburg, Palmyra, Perry County, , Pottsville, Shippensburg, State College, and York. Complete a FREE Online Consultation Form or call us today.