IMPORTANT SAFETY INFORMATION Harmony Transcatheter Pulmonary Valve

RISKS YOU SHOULD KNOW

Possible risks of the Harmony TPV therapy include the following:

  • Death
  • Irregular valve function, including narrowing of the valve
  • Parts of the valve or valve tissue breaking down
  • Bruising
  • Heart failure
  • Stroke (a condition in which decreased blood flow to the brain causes brain cells to die)
  • Poking a hole in a large blood vessel (perforation)
  • Rupture of the area between the pumping chamber and lung artery
  • Pressing of the valve against the parts of the heart that could affect blood flow
  • Infection in the bloodstream
  • Bulging of the blood vessel causing blood to leak into the surrounding areas of the heart
  • Wearing away of heart tissue where the valve the valve is implanted
  • Break (fracture) in the valve frame
  • Irregular rate or rhythm of the heartbeat
  • Movement of the valve from where it was placed
  • A piece of blood clot, air, or heart tissue traveling to and causing problems with lung function
  • Blocking of the main artery to the lungs
  • Placement of the valve in an unplanned location or upside down (misorientation)
  • Backward flow of blood through the valve
  • Leakage around the valve frame
  • Not enough (inadequate) blood flow through the valve
  • Thickening of the valve preventing proper blood flow to lungs
  • Unexpected bleeding that may require a blood transfusion
  • Infection of the heart valve
  • A blood clot can form, and may travel to another part of the body
  • Weakening of the valve or buildup of calcium on the valve, leaflets, or tissue
  • Bleeding problems, which could be major or life-threatening
  • Bleeding caused by blood thinning medication used during the procedure
  • Fever
  • Pain or swelling at the site where the catheter was inserted
  • Allergic reaction to X-ray dye
  • Infection
  • High blood pressure in the lungs
  • Thickening or peeling of the heart wall
  • Damage to red blood cells