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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”.

 

Caution: U.S. federal law restricts the sale, distribution, and use of this product to physicians or as prescribed by a physician. This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures, and the physician would have successfully completed training. Indications for Use: LAVA® LES is indicated for embolization of arterial hemorrhage in the peripheral vasculature. Potential Complications: Potential adverse effects (e.g., complications) associated with the use of the device 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 atheroembolism, Infection, Sepsis, Serous drainage, Lymphorrhea, Leg edema, Leg pain, and Back pain. Consult the Instructions for Use for a complete listing of indications, contraindications, potential complications, warnings, and precautions.