NeVa VS Instructions for Use

• The Vesalio NeVa Mechanical Thrombectomy System should only be used by physicians who have received appropriate training in interventional neuroradiology and treatment of acute ischemic stroke, and/or the appropriate training in interventional cardiology.
• Select a device size and configuration to engage the clot and to maintain sufficient vessel coverage on each side of the embolus along the parent vessel. An incorrectly sized device may result in no blood flow restoration and/or embolus migration.
• The Vesalio NeVa Mechanical Thrombectomy System family of products, as noted in the Recommended Sizing Guideline Table, is designed for use in vessels ≥ 2mm and ≤ 6mm in diameter. Use of the device in vessel diameters outside the recommendation can produce excessive resistance forces on the vessel and device components. If excessive resistance is encountered during the use of the device or any of its components at any time during the procedure, discontinue use. Movement of the device against resistance may result in damage to the vessel or a device component.
• The device is provided STERILE for single use only. Reusing the device could result in compromised device performance, cross-infection and other safety related hazards.
• Store in a cool, dry place.
• Do not re-sterilize. After use, dispose in accordance with hospital, administrative and/or local government policy.
• Use the device prior to the ‘Use Before’ date printed on the package.
• Carefully inspect the sterile package and device prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.
• The Vesalio NeVa Mechanical Thrombectomy System has not been shown to be MRI compatible.
• The device should not be removed or repositioned without recapturing within the introducer Microcatheter unless thrombectomy is being attempted.
• Exercise caution when crossing the deployed device with adjunctive devices (e.g., micro catheter).
• Tighten the Rotating Hemostasis Valves sufficiently to create an adequate hemostasis seal without crushing the introducer microcatheter and Vesalio NeVa Mechanical Thrombectomy System shaft. Inadequately tightening the Rotating Hemostasis Valves may lead to premature deployment of the device.
• After deployment, the distal tip of the device may foreshorten.
• Do not steam shape or use pre-shaped microcatheters for the Vesalio NeVa Mechanical Thrombectomy System introducer microcatheter because it could damage the device.
• The Vesalio NeVa Mechanical Thrombectomy device is delivered to, positioned in the occluded vasculature, unsheathed, and then retrieved in order to capture clot and restore flow. Should the first attempt at flow restoration fail, the device can be recaptured into its introducer sheath, and redeployed as described earlier. The system can be used in conjunction with any proximal flow control strategy preferred by the physician (examples: manual aspiration, pump aspiration, flow arrest with balloon guide catheter).

Additional warnings and precautions specific to the NeVa VS:

• A maximum of six deployments and retrievals of a single NeVa VS should be performed.
• A maximum of three deployments over the same vessel segment with NeVa VS should be performed.
• If excessive resistance is encountered during the delivery of the Vesalio NeVa VS, discontinue the delivery, and identify the cause of the resistance. Advancement of the Vesalio NeVa VS against resistance may result in device damage and/or patient injury.
• If excessive resistance is encountered during microcatheter re-capture of the Vesalio NeVa VS, discontinue the re-capture and identify the cause of the resistance. If there is continued resistance, withdraw the microcatheter and Vesalio NeVa VS together and re-capture into the guide catheter.
• Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
• The NeVa VS should be used in conjunction with a microcatheter with a minimum ID of .021.