Indication for Use

The pVasc Thrombectomy Device is indicated for:

  • The non-surgical removal of emboli and thrombi from peripheral blood vessels,
  • Temporary use in peripheral vessel occlusion,
  • Use with aspiration and with the injection or infusion of contrast media and other fluids

 

CAUTION: Evaluate the risks associated with peripheral vascular interventional therapy (see complications below) and the possible benefits of immediate flow restoration prior to use of the Vesalio pVasc Mechanical Thrombectomy System.

CONTRAINDICATIONS

  • Patient presents with nickel allergy
  • Patients with suspected or known allergies to contrast media
  • Pregnancy
  • Dilatation of plaque-obstructions or stenoses
  • Removal of calcified or fibrous material
  • Coronary or neurovascular use
  • Blood vessels occluded with calcified material
  • Infected vessels
  • Blood vessels with extreme tortuosity or other conditions preventing the access of the device
  • Patients with a known hypersensitivity or allergy to nitinol
  • Blood vessels with a reference diameter less than 2.0 mm or greater than 6.0mm

Warnings

  • The Vesalio pVasc Mechanical Thrombectomy System should only be used by physicians who have received appropriate training in interventional radiology procedures.
  • 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 pVasc 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.
  • Store in a cool, dry place.

Precautions

  • Tighten the Rotating Hemostasis Valves sufficiently to create an adequate hemostasis seal without crushing the introducer microcatheter and Vesalio pVasc Mechanical Thrombectomy System shaft. Inadequately tightening the Rotating Hemostasis Valves my lead to premature deployment of the device.
  • Do not torque or turn the device
  • Do not steam shape or use pre-shaped microcatheters for the Vesalio pVasc Mechanical Thrombectomy System introducer microcatheter because it could damage the device.
  • 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 pVasc Mechanical Thrombectomy System has not been shown to be MRI compatible.

Precautions

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

  • death,
  • nerve injury,
  • compression,
  • irritation,
  • cardiac dysrhythmia,
  • vessel dissection,
  • emergency surgery to correct vascular complications,
  • perforation,
  • continued total occlusion of affected arterial segment,
  • hemorrhage,
  • hematoma,
  • arteriovenous fistula formation,
  • pseudoaneurysm formation,
  • vasospasm,
  • hypotension,
  • hypertension,
  • air embolism,
  • distal embolization of thrombus,
  • recurrence of thrombosis,
  • allergic reactions to device materials, drugs, or contrast medium,
  • infection, sepsis,
  • renal insufficiency, renal failure,
  • respiratory complications, or
  • device events: ex. failure to deliver device to intended site, failure to fully expand or contract basket at intended site, device fracture, etc.
  • Device(s) deformation, collapse, fracture or malfunction