LAVA®
Risk and Potential Adverse Events
Almost all treatments and drugs produce potentially unwanted side effects.
Most side effects following a LAVA Liquid Embolic System (LAVA LES) procedure are not serious, making patients feel uncomfortable.
The most common adverse events after receiving LAVA LES are:
- Abdominal pain
- Nausea / vomiting
- Pleural effusion
- Ileus
- Pyrexia
- Sepsis
- Flank pain
- Tachycardia
- Anemia
The most common serious adverse events after receiving LAVA LES are:
- Sepsis
- Anemia
- Extravasation of blood
- Death
- Atrial fibrillation
- Melaena
- Flank pain
- Vascular pseudoaneurysm
Potential adverse events or complications that are associated with using LAVA LES include:
- Non-target embolization
- Ischemia or infarction of the target territory
- Allergic reactions to device components
- Catheter breakage
- Catheter entrapment
- Inadvertent embolization of a non-target vessel or territory
- Embolization of device components
- Access site hematoma or ecchymosis
- Access site false aneurysm
- Pain at access site
- Arterial dissection
- Mural thrombus formation
- Vessel perforation
- Hemorrhage
- Recanalization
- Vessel perforation
- Arteriovenous fistula
- Distal atheroembolizm
- Infection
- Sepsis
- Serous drainage
- Lymphorrhea
- Leg edema
- Leg pain
- Back pain
Patients should consult their doctor to understand the risks so they may consider the benefits of the treatment with the risks before making a decision.
For more information, please refer to the Package Insert under the page “Approved Indication”.