All of the possible complications of ELANA are not yet fully known. However, it is believed that the potential risks would be similar to those of standard bypass procedures that are currently in use. The following is a list of potential risks that may be associated with the ELANA, as well as the potential risks of the artery bypass procedure in general. Those specifically associated with ELANA are noted as such.
Risks of bypass procedures in general
- A blood clot (embolus) may result in brain injury, stroke, or pulmonary embolism.
- A hole or tear at a suture site, in the bypass, in an adjacent artery, or in the aneurysm or pseudo-aneurysm may cause bleeding. This hemorrhagic event may lead to brain injury, may require surgery to repair the hole or tear, and may even cause death.
- Bypass deformity, kinking, or thrombosis (clot formation) may require additional surgery and may result in brain injury, bleeding, stroke, and can cause death.
- Pushing and holding the brain aside in order to perform the bypass may result in temporary or permanent damage. Injection of contrast dye for angiograms may cause an allergic reaction which may produce side effects.
- Incomplete closure of the aneurysm, removal of tumor, or failure to establish a working bypass may require additional treatment or surgery.
- Narrowing of arteries or bypass graft during procedures may require additional surgical repair and prolong surgery.
- Temporary narrowing (spasm) of the graft or arteries may reduce blood supply to the brain, which may result in stroke and can cause death.
- Surgery, anesthesia, or angiography may cause complications including hydrocephalus (“water on the brain”), emboli (blood clots), bleeding, perforation, allergic reactions, mechanical damage, respiratory failure, or infections, all of which could be fatal or cause permanent damage.
- Drawing blood for tests may result in slight bruising, pain, and may cause infection.
- Reduced kidney capacity or kidney failure may require medication or lead to chronic (long-term) dialysis.
- Temporary occlusion of the artery may result in brain injury or ischemic stroke.
- The aneurysm can start to bleed after the bypass has been made, flow to the aneurysm has not yet been completely stopped, which may lead to brain injury and can lead to death.
Risks specifically associated with ELANA
The use of the ELANA or its accessories may damage arteries or the bypass itself and also may cause bleeding, occlusion (blockage of the artery) or clot formation. These conditions may cause stroke leading to other complications and death.
- Incorrect positioning or imperfect cutting of the ELANA System may cause bleeding or thrombosis (clot formation) and may require further surgery and may cause death.
- A longer surgery time with the ELANA System may increase the risk of failure of one or more organs.
- Contact with parts of the Elana system or its accessories may cause allergic reactions