HeartMate II® Left Ventricular Assist System Recall

HeartMate II® Left Ventricular Assist System is a device made by Thoratec meant to assist in quality of life and to improve survival rates by providing circulatory support for advanced heart failure patients.  It is primarily a heart pump called an LVAD for short (Left Venticular Assist Device) and is meant to help the left side of a patient’s heart to pump blood that the body requires.  Its small size and method of quiet operation make the HeartMate II a suitable standard for a wider range of patients, which includes women and those of a smaller stature.  The complications of LVAD surgery are just as complicated as any open-heart surgery.

Possible serious adverse side effects include the following:

• Death
• Bleeding, preoperative or later
• Cardiac arrhythmia
• Local infection
• Respiratory failure
• Device malfunction
• Sepsis
• Right heart failure
• Driveline infection
• Pocket infection
• Renal failure
• Stroke
• Neurologic dysfunction
• Psychiatric episode
• Thromboembolic event, peripheral
• Hemolysis
• Hepatic dysfunction
• Device thrombosis
• Myocardial infarction

Although most patients who are candidates for mechanical circulatory support are listed for transplants, there are a series of factors that compel a heart surgeon against going right to transplant including multiple reoperations, restrictive heart disease that has induced small ventricles, congenital heart anomalies and other issues that must be judged upon a case by case basis, ie. the prospects of success and the patient’s quality of life is also another factor.  These are all contraindications.  However HeartMate II LVAD might be contraindicated in patients who are extremely underweight or extremely overweight.  Overweight patients are particularly at risk of driveline infections after the transplantation of the HeartMate II LVAD.  The most important contraindication to LVAD therapy is that of a patient’s right ventricle to be unable to support LVAD flows.  It isn’t unusual to require a right ventricular support system working in conjunction with a LVAD concurrently.

As of April 4, 2012 the FDA is notifying health care professionals of a Class I Recall due to the detachment of bend relief from HeartMate’s II LVAD’s positioning in a patient’s heart around the proximal outflow graft, which can allow the graft to deform or to kink, resulting in a reduction of blood flow from the HeartMate II LVAD pump, perforation of the outflow graft, or pump and graft thrombosis.  In addition to that, the metal end of the bend relief can be sharp and cause cutting and erosion of the outflow graft.  These factors can lead to a patient’s death.