Potential Risks and Benefits of the Spiration Valve System FOR TREATMENT OF AIR LEAKS

Warnings

  • All or part of your lung may collapse (atelectasis) after the air leak in your lung closes. You will be watched for this possible problem.

Precautions

  • If you have swelling of airways (active asthma), inflammation of lung tissue (bronchitis), or airways that have gotten larger and/or infected (bronchiectasis), you should not have Spiration Valves placed in your lungs.
  • You will be given drugs to make you unaware of pain. These will make you sleepy (sedation) or unconscious (anesthesia). Talk with your doctor about the problems that can occur with sedation or anesthesia.
  • Your doctor will not place a Spiration Valve(s) in your airway for any reason other than its intended use.
  • The Spiration Valves are MR-conditional, which means that you can have an MRI procedure (a method for taking pictures of your internal organs) while the valves are implanted in your lungs under certain conditions. You will be given an information card to carry in your wallet. Show this card to a health care professional if you require an MRI.
  • Although rare, as with all drugs and devices, it is possible that you may have an allergic reaction to the materials used in the Spiration Valve System.

Potential Risks

Please discuss these potential risks with your doctor. Call your doctor immediately if you have any discomfort, pain or any other concerns after your procedure.

 

Potential Risks Related to the Procedure

 

Reported Occurrence of Risks in 987 Patients Treated From 10/2008 to 10/2013

You may have problems from medications used to make you comfortable or unconscious (sedation, anesthesia) and/or from the tube put down your throat (intubation). Problems may include the failure to be able to be taken off a breathing machine (ventilator).

0 out of 987 Patients

You may have swelling inside of your lungs that could make breathing hard and make your recovery time longer. This problem may require you to get breathing help and medicines.

0 out of 987 Patients

You may get inflammation in your lungs (bronchitis) or fever/infection (pneumonia).

0 out of 987 Patients

You may have a cough that lasts a long time.

0 out of 987 Patients

You may develop shortness of breath or your shortness of breath may get worse.

0 out of 987 Patients

The area of your lung near or around the valve(s) may be damaged by the narrow tube used to perform the procedure (bronchoscope).

0 out of 987 Patients

Heart problems, including changes in blood pressure and changes in heart rhythm, may make your recovery more difficult and require medicines.

0 out of 987 Patients

Severe problems may require you to get medical treatment or even surgery. A severe problem may result in death.

0 out of 987 Patients

 

Potential Risks Related to the Spiration Valves

Reported Occurrence of Risks in 987 Patients Treated From 10/2008 to 10/2013

The valve(s) may move or wear away your lung tissue. The valve(s) may become loose and may move out of place or be coughed out of your lungs.

0 out of 987 Patients

The valve(s) may cause swelling or irritate the inside of your airway or lung.

1 out of 987 patients (0.1%)

Damage may occur to the inside of your airway from the normal movement of the valve(s).

0 out of 987 Patients

You may get inflammation (bronchitis) or fever/infection (pneumonia).

0 out of 987 Patients

You may have a cough that lasts as long as you have the valve(s) in place.

0 out of 987 Patients

You may experience shortness of breath or your shortness of breath may get worse.

0 out of 987 Patients

There may be some bleeding or a new air leak in the area(s) of your lung that has the valve(s), which may not stop and may require treatment or surgery.

0 out of 987 Patients

There may be some bleeding at the time of valve removal, which can interfere with breathing or require another procedure to remove a blood clot.

1 out of 987 patients (0.1%)

Your air leak may not get any better or may get worse from having the valve(s).

0 out of 987 Patients

The area of your airway and/or lung near or around the valve(s) may be damaged from handling of the valve(s).

0 out of 987 Patients

The area of your lung that has a valve(s) may lose air and shrink.

0 out of 987 Patients

The areas of your lung without valve(s) may grow, which may tear the lung, and result in additional air leaks.

0 out of 987 Patients

Severe problems may require you to get medical treatment or even surgery. A severe problem may result in death.

0 out of 987 Patients

 

Potential Benefits

  • Spiration valves may stop or reduce the amount of air flowing to portions of your lung with an air leak. This reduction of air flow may help your lung heal faster than it would with more air flowing through it. How fast an air leak heals is different for each patient because it depends on the size of the air leak, the condition of the surrounding lung tissue, and your general health.
  • Stopping an air leak may allow your chest tube(s) to be removed sooner than they would be without valve placement.
  • Stopping or reducing an air leak may allow a patient to be taken off a machine used to help with breathing (ventilator) or off a machine that keeps the lungs inflated (suction).
  • Stopping or reducing an air leak may allow a patient to be moved from a critical care unit to a general ward.
  • Stopping or reducing an air leak may allow you to be discharged sooner.
  • Stopping or reducing an air leak may reduce your potential for additional surgery. This may be important because surgeries can be difficult to recover from and may increase the chance of medical problems and hospitalizations.