Your browser is out of date

With an updated browser, you will have a better Medtronic web site experience. Update my browser now.

×

Menu

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
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Your information will be used and protected in accordance with our {link}

There are items that require your attention.
United States

Customer Care Team

Hours: 8:00 a.m. - 8:00 p.m. EST 

 

Phone: 763-514-4000

Toll-free: 800-633-8766

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Just to confirm, is this the product or product type that interests you?

{{productNamePlaceholder}}

OR

There are items that require your attention.

OR

There are items that require your attention.

There are items that require your attention.

OR

There are items that require your attention.
There are items that require your attention.

There are items that require your attention.
There are items that require your attention.

OR

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.

OR

OR

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Your personal data will be used to manage your relationship with Medtronic in accordance with our {link}

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

If you consent to receive emails, you can unsubscribe anytime via the link in each email. We use technology that measures email opens and clicks, to improve our communications and provide relevant content. For details, see our {link}