LC Bead LUMI™ Brief Summary

INDICATIONS

LC Bead LUMI Device is indicated for the embolization of hypervascular tumors (HVTs) and arteriovenous malformations (AVMs).

CONTRAINDICATIONS

• Patients intolerant to occlusion procedures.
• Vascular anatomy or blood flow that precludes catheter placement or injection of embolics.
• Presence or likely onset of vasospasm.
• Presence or likely onset of hemorrhage.
• Presence of severe atheromatous disease.
• Presence of feeding arteries smaller than distal branches from which they emerge.
• Presence of patent extra-to-intracranial anastomoses or shunts.
• Presence of end arteries leading directly to cranial nerves.
• Presence of arteries supplying the lesion/tumor not large enough to accept the beads.
• Vascular resistance peripheral to the feeding arteries precluding passage of beads into the lesion/tumor.
• Presence of collateral vessel pathways potentially endangering non-target tissue during the embolization procedure that cannot be coiled or blocked.
• Presence of high-flow arteriovenous (AV) shunt with a diameter greater than the selected bead size that cannot be coiled or blocked.
• Do not use LC Bead LUMI Device in the following applications:
  • Embolization of AV shunts (i.e., where the blood does not pass through the arterial/capillary/venous transition but directly fromartery to vein).
  • Any vasculature where the beads could pass directly into the internal carotid artery or other non-target territories.
  • Any neurovascular indication.
  • Pulmonary arterial vasculature.

WARNINGS

The following warning statements provide important information for safe use of LC Bead LUMI Device. Observe all warnings provided in these instructions for use. Failure to do so may result in patient injury or product damage.

• Non-target embolization may occur in the presence of AV anastomosis, branch vessels which lead away from the targeted embolization area, or emergent vessels not evident prior to embolization. The patient may experience severe complications as a result of non-target embolization. Special care should be taken to avoid ischemia of non-tolerant, non-targeted tissue.
• Bead embolization must be performed slowly. The injection speed and manner must be controlled. Excessive injection rate may result in retrograde flow in the vessel, leading to embolization of other non-target healthy tissue or organs.
• If there are any symptoms of unwanted embolization during injection, consider stopping the procedure to evaluate the possibility of shunting. Such symptoms may include changes in patient’s vital signs, such as hypoxia or central nervous system changes.
• When prepared according to instructions, this product contains contrast and iodine, which may cause an allergic reaction for patients who may be allergic or with known sensitivity to contrast and/or iodine/iodine-containing substances.
• Patients with prior biliary surgery, bile duct dilation, or vessels close to bile ducts may be at increased risk from infection (e.g., biloma/liver abscess).
  

PRECAUTIONS 

The following precaution statements provide important information for safe use of LC Bead LUMI Device. Observe all precautions provided in these instructions for use. Failure to do so may result in patient injury or product damage.

• Consideration should be given to Tc99m-MAA scanning if there is a suspicion of AV shunting. This will enable analysis of lung shunting. Angiographic confirmation that AV shunting is no longer present must be obtained before bead injection can be performed.
• Select the size and quantity of beads appropriate for the pathology to be treated (i.e., vascular target/vessel size/AVM nidus).
• Use only the recommended non-ionic contrast agents .
• Consider risks of radiation from angiography and fluoroscopy used to visualize the blood vessels during embolization, which may include a radiation burn and risks to future fertility.
• A maximum of 4 vials of beads can be used in a single treatment session.
• Do not use if the vial or packaging appears damaged.
• Sterile and single-use product. Do not reuse.
  

ADVERSE EVENTS

Potential adverse events which may be associated with vascular embolization procedures or the use of LC Bead LUMI Device include but are not limited to:

• Allergic reaction (to contrast and/or iodine)
• Capillary bed saturation and tissue damage
• Cerebral vascular accident (CVA)/stroke/transient ischemic attack (TIA)
• Death
• Foreign body reactions
• Hematoma
• Hemorrhage
• Hypertension/hypotension
• Infection/abscess/sepsis
• Ischemia at an undesirable location
• Ischemia/necrosis
• Lesion/tumor rupture, injury
• Neurological deficits, including cranial nerve palsies
• Non-target embolization, for example:
  • Pancreatitis
  • Pulmonary embolism
• Post-embolization syndrome (PES) (pain/discomfort, fever, and/or nausea/vomiting)
• Recanalization
• Thrombus/thrombosis, including deep vein thrombosis or clot in tip of catheter
• Undesirable reflux or passage of beads into normal arteries adjacent to the targeted lesion/tumor, or through the lesion/tumor into other arteries or arterial beds
• Vasospasm
• Vessel trauma (aneurysm, dissection, injury, perforation, pseudoaneurysm, and/or rupture)

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