NeVa VS Instructions for Use

Indications, Safety, and Warnings

Indication for Use

The NeVa VS is indicated for use as an adjunct treatment for symptomatic cerebral vasospasm in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery caused by aneurysmal subarachnoid hemorrhage in adults 22 years of age or older who have exhausted maximal medical treatment and have had the intracranial aneurysm secured by either surgical or endovascular intervention. Symptomatic cerebral vasospasm is defined as more than 50% narrowing of the indicated cerebral vessels confirmed by angiographic imaging and a decreased level of consciousness or a focal neurological deficit.

Contraindications

The NeVa VS is contraindicated for use in patients with:
  • An unsecured, ruptured intracranial aneurysm.
  • An allergy to the NeVa VS components (nickel).
  • Suspected or known allergies to contrast media.
  • Pregnancy.
  • Excessive vessel tortuosity that prevents the placement of the device.
  • Known hemorrhagic diathesis, coagulation factor deficiency or oral anticoagulant therapy with international normalized ratio (INR) > 1.7.
  • Baseline platelets < 30,000.
  • Evidence of rapidly improving neurological signs of stroke.
  • Large territory completed cerebral infarction, edema with mass effect and intra-parenchymal hemorrhage in vascular territory to be treated.

Warnings

  • No more than a total of six (6) device interventions per vessel should be attempted in a single procedure; a single device or multiple devices may be used during the procedure.
  • Successive, later interventions on the same vessel in multiple separate procedures with the NeVa VS is not recommended and is not supported by clinical data with the NeVa VS.
  • The Vesalio NeVa VS, as noted in the Recommended Sizing Guideline Table, is designed for use in vessels with a pre-vasospasm diameter of ≥ 2.0 mm and ≤ 4.0 mm. Use of the device in vessels with diameters outside the recommended range may result in vessel injury.
  • Tighten the Rotating Hemostasis Valves sufficiently to create an adequate hemostasis seal without crushing the introducer sheath and the Vesalio NeVa VS shaft. Inadequately tightening the Rotating Hemostasis Valves my lead to premature deployment of the device.
  • 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. Do not perform more than six deployments and microcatheter re-sheathing attempts using a single Vesalio NeVa VS.
  • The Vesalio NeVa VS has not been evaluated for safety in the magnetic resonance (MR) environment. Do not use the NeVa VS in the MR environment.
  • The device is provided STERILE for single patient use only. Reusing the device could result in compromised device performance, cross-infection and other safety related hazards.
  • Do not re-sterilize. After use, dispose in accordance with hospital, administrative and/or local government policy.
  • The safety and probable benefit of the NeVa VS in cerebral vessels with an endoluminal stent has not been evaluated and is not supported by the clinical data with the NeVa VS.

PRECAUTIONS

  • The Vesalio NeVa VS should only be used by physicians who have received appropriate training in cerebral endovascular techniques.
  • 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 with the Trevo Pro 18 Microcatheter and a guide catheter compatible with the Trevo Pro 18 Microcatheter in accordance with its product labeling.
  • Store in a cool, dry place. Page 5 of 19
  • Use the device prior to the ‘Use By Date’ 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.
  • After deployment, the distal tip of the device may foreshorten.

COMPLICATIONS

Potential complications include but are not limited to:

  • Vessel perforation or dissection
  • Air embolism
  • Subarachnoid or interventricular hemorrhage due to vessel perforation
  • Vascular spasm or vascular occlusion
  • Neurologic deterioration
  • Distal embolization including to a previously uninvolved territory
  • Pseudoaneurysm formation
  • Device(s) deformation, collapse, fracture or malfunction
  • Displacement of coils or clips used to secure an intracranial aneurysm
  • Intraprocedural thrombotic events
  • Cerebral ischemia
  • Coagulopathy
  • Confusion
  • Death
  • Embolic stroke
  • Hematoma, pain, infection at access site
  • Intracerebral/intracranial hemorrhage
  • Post-procedure bleeding
  • Renal failure
  • Vessel thrombosis

Possible complications of exposure to Xray radiation as part of the fluoroscopic guidance include but are not limited to:

  • Alopecia
  • Burns ranging in severity from skin reddening to ulcers
  • Cataracts
  • Delayed neoplasia

Please note these potential complications increase as the length and number of procedures increase.