LC Bead™, LC Bead M1™ Embolic Bead Brief Summary

INDICATIONS

LC Bead Device and LC Bead M1 Device are 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 collateral vessel pathways potentially endangering non-target tissue during embolization.
• Presence of end arteries leading directly to cranial nerves.
• Presence of arteries supplying the lesion not large enough to accept the beads.
• Vascular resistance peripheral to the feeding arteries precluding passage of beads into the lesion.
• Do not use LC Bead Device/LC Bead M1 Device in the following applications:
  • Embolization of large-diameter arteriovenous (AV) shunts (i.e., where the blood does not pass through the arterial/capillary/venous transition but directly from artery to vein).
  • Pulmonary arterial vasculature.
  • Any vasculature where the beads could pass directly into the internal carotid artery or the above listed vessels.
    

WARNINGS

The following warning statements provide important information for safe use of LC Bead Device/LC Bead M1 Device. Observe all warnings provided in these instructions for use. Failure to do so may result in patient injury or product damage.

• When prepared according to instructions, this product contains contrast, which may cause an allergic reaction for patients who may be allergic or with known sensitivity to contrast.
• Studies have shown that the beads do not form aggregates, and, as a result, penetrate deeper into the vasculature as compared to similarly-sized PVA particles. Care must be taken to choose a larger-sized bead when embolizing AVMs with large shunts to avoid passage of the product into the pulmonary or coronary circulation.
• 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.
• Monitor patients carefully for signs of non-target embolization, such as hypoxia or central nervous system (CNS) changes.
• 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 Device/LC Bead M1 Device.Observe all precautions provided in these instructions for use. Failure to do so may result in patient injury or product damage.

• Do not use if the vial or packaging appears damaged.
• Select the size and quantity of beads appropriate for the pathology to be treated.
• Sterile and single-use product. Do not reuse.
• Consideration should be given to Tc99m-MAA scanning if there is a suspicion of AV shunting. This will enable analysis of lung shunting.
• The color of the beads could be visible through the skin if injected into arteries feeding superficial tissues.

Precautions Associated with LC Bead M1 Device

• Ensure that LC Bead M1 Device is an appropriate size for the intended vasculature.
• Consider upsizing to a larger size of LC Bead Device if angiographic evidence of embolization does not appear quickly during delivery.
  

ADVERSE EVENTS

Potential adverse events which may be associated with vascular embolization procedures or the use of LC Bead Device/LC Bead M1 Device include but are not limited to:

• Allergic reaction (to contrast)
• 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 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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