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Safety information

IMPORTANT INFORMATION

This information is provided for educational purposes. Individual experiences, symptoms, situations, and circumstances may vary. Please consult your physician or qualified healthcare provider regarding your condition and appropriate medical treatment.

Indications: The HeartMate II LVAS is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate II LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II LVAS is intended for use both inside and outside the hospital.

Contraindications: The HeartMate II LVAS is contraindicated in people who cannot tolerate or are allergic to anticoagulation therapy.

Complications and adverse events: Complications of VAD surgery are similar to the potential complications of any open heart surgery procedure. You will be asked to sign a surgical consent form prior to the operation, as well as a consent form for blood transfusions. Your surgeon will discuss potential risks and benefits with you prior to the procedure.

Possible serious adverse events include the following:

  • Death
  • Bleeding, during surgery or after surgery
  • Cardiac arrhythmia (irregular heartbeat)
  • Local infection
  • Respiratory failure
  • Device malfunction
  • Sepsis (serious infection)
  • Right heart failure
  • Driveline or pocket infection
  • Renal failure (inability of the kidneys to remove waste from the blood)
  • Stroke
  • Neurologic dysfunction (problems affecting the brain or nervous system)
  • Psychiatric episode
  • Thromboembolic event, peripheral (blood clots)
  • Hemolysis (breakdown of red blood cells)
  • Hepatic dysfunction (liver problems)
  • Device thrombosis (formation of a blood clot inside the device)
  • Myocardial infarction (heart attack)

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