LVIS™ EVO™ Indications, Safety, and Warnings

Warnings and Precaution

Contraindications

Use of the LVIS EVO device is contraindicated under these circumstances:  

• Patients in whom anticoagulant, anti-platelet therapy or thrombolytic drugs are contraindicated;  

• Patients with known hypersensitivity to metal, such as nickel-titanium and metal jewelry;  

• Patients with anatomy that does not permit passage or deployment of the LVIS EVO device;  

• Patients with an active bacterial infection;  

• Patients with a pre-existing stent in place at the target aneurysm. 

Warnings

Should unusual resistance be felt at any time during access or removal, the introducer/guide catheter/microcatheter and LVIS EVO device should be removed as a single unit. Applying excessive force during delivery or retrieval of the LVIS EVO device can potentially result in loss or damage to the device and delivery components.

The LVIS EVO device should only be used by physicians trained in endovascular interventional neuroradiology, radiology, neurosurgery or interventional neurology for the treatment of intracranial aneurysms or other vascular lesions.

It is imperative to use the LVIS EVO device with compatible microcatheters. If repeated friction is encountered during LVIS EVO device delivery, verify microcatheter is not kinked or in extremely tortuous anatomy. Confirm that the microcatheter does not ovalize. Confirm that there is adequate sterile flush solution.

Do not reposition the LVIS EVO device in the parent vessel without fully retrieving the device. The LVIS EVO device MUST be retrieved into the microcatheter and re-deployed at the desired target location or removed completely from the patient.

Do not attempt to re-position the LVIS EVO implant after detachment.

Do not shape the tip of the delivery wire. 

Precautions

This product should only be used by experienced physicians who have completed endovascular training in the use of the LVIS EVO device for angiographic, percutaneous neurointerventional and peripheral vascular procedures as prescribed by an authorized representative of Terumo Neuro.

The LVIS EVO device is provided sterile for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Carefully inspect the sterile package and the LVIS EVO device prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components, or if the packaging is damaged.

See the product label for the device shelf life. Do not use the device beyond the labeled use by date.

Exercise caution when crossing the deployed/detached LVIS EVO device with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement.

Potential Complications

Possible complications include but are not limited to the following:  

• Hematoma at the puncture site  

• Perforation or dissection of the vessel(s)  

• Intravascular spasm  

• Hemorrhaging  

• Rupture or perforation of aneurysm  

• Coil herniation  

• Device migration  

• Neurologic insufficiencies including stroke and death  

• Ischemia  

• Vascular occlusion  

• Vessel stenosis  

• Incomplete aneurysm occlusion  

• Pseudoaneurysm formation  

• Distal Embolization  

• Headache  

• Infection  

• Reaction to contrast agents including severe allergic reactions and renal failure