NeVa & NeVa Net Instructions for Use

Indications, Safety, and Warnings

Indication for Use

The Vesalio NeVa & NeVa Net Mechanical Thrombectomy System is indicated for:

  • Endovascular temporary use in patients with acute ischemic stroke
  • Endovascular temporary use to restore blood flow in patients who are experiencing symptoms of an acute ischemic stroke caused by an embolus in a cerebral vessel
  • Endovascular temporary use to restore blood flow in patients who are experiencing symptoms of thrombosis in the coronary vasculature

CONTRAINDICATIONS

The Vesalio NeVa & NeVa Net Mechanical Thrombectomy System is indicated for:

  • Coma
  • CT/MRI scan reveals significant mass effect with midline shift (ischemic stroke only)
  • Delivery of pharmacological agents not routinely used to treat ischemic stroke or thrombosis in the coronary vasculature
  • Do not use the device in calcified lesions
  • Evidence of rapidly improving neurological signs of stroke (for ischemic stroke interventions)
  • Excessive vessel tortuosity that prevents the placement of the device
  • Glucose <50mg/dl
  • Coma
  • CT/MRI scan reveals significant mass effect with midline shift (ischemic stroke only)
  • Delivery of pharmacological agents not routinely used to treat ischemic stroke or thrombosis in the coronary vasculature
  • Do not use the device in calcified lesions
  • Evidence of rapidly improving neurological signs of stroke (for ischemic stroke interventions)
  • Excessive vessel tortuosity that prevents the placement of the device
  • Glucose <50mg/dl

Warnings and Precautions

  • The Vesalio NeVa & NeVa Net 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 & NeVa Net 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 & NeVa Net 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 or NeVa Net 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 & NeVa Net Mechanical Thrombectomy System introducer microcatheter because it could damage the device.
  • The Vesalio NeVa or NeVa Net 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).

Risks and Undesirable Side Effects

Evaluate the risks associated with acute endovascular ischemic stroke therapy or clot removal in the coronary vasculature and the possible benefits of immediate flow restoration prior to use of the Vesalio NeVa & NeVa Net Mechanical Thrombectomy System.

Possible complications of the use of the Vesalio NeVa & NeVa Net Mechanical Thrombectomy System include but are not limited to: 

  • Acute occlusion
  • Adverse reaction to device materials
  • Air embolism
  • Arterial perforation with guidewire
  • Clot formation
  • Distal embolization including to a previously uninvolved territory
  • False/Pseudo aneurysm formation
  • Neurologic deterioration including stroke and death
  • Perforation or dissection of the vessel
  • Subarachnoid/interventricular hemorrhage or pericardial effusion and myocardial tamponade due to vessel perforation from guidewire placement or device microcatheter placement
  • Vascular spasm or vascular occlusion

Complications of routine endovascular revascularization include: 

  • Arterial Injury (dissection, perforation) associated with arterial catheter insertion
  • Cerebral/myocardial ischemia
  • Coagulopathy
  • Confusion
  • Death
  • Embolic stroke/myocardial infarction
  • Hematoma, pain, and/or infection at access site
  • Intracerebral/intracranial/pericardial hemorrhage
  • Infection
  • Post-procedure bleeding
  • Pseudoaneurysm formation
  • Renal failure
  • Vessel and soft tissue damage
  • Vessel thrombosis