Solitaire™ X Revascularisation Device Indications, Safety, and Warnings

INDICATIONS FOR USE

The Solitaire™ X Revascularisation Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

CAUTION

The Solitaire™ X Revascularisation Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

PRECAUTIONS

• The Solitaire™ X Revascularisation Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.
• Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.
• Carefully inspect the sterile package and the Solitaire™ X revascularisation device prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.
• The Solitaire™ X Revascularisation Device is not to be used after the expiration date imprinted on the product label.
• Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labelling for indications, contraindications, warnings, precautions, and instructions for use.
• Initiate mechanical thrombectomy treatment as soon as possible.

CONTRAINDICATIONS

Use of the Solitaire™ X Revascularisation Device is contraindicated under these circumstances.

• Patients with known hypersensitivity to nickel-titanium.
• Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the Solitaire™ X revascularisation device.
• Patients with angiographic evidence of carotid dissection.

COMPATIBILITY

Introducer sheath size and maximum guidewire diameter are indicated on the product label. 

POTENTIAL COMPLICATIONS

Possible complications include, but are not limited to, the following:

• Adverse reaction to antiplatelet/ anticoagulation agents or contrast media
• Air Embolism
• Allergic reactions
• Arteriovenous Fistula
• Brain Edema
• Change in mental status
• Device(s) deformation, collapse, fracture or malfunction
• Distal embolisation including to a previously uninvolved territory
• Hematoma and hemorrhage at puncture site
• Infection
• Inflammation
• Intracranial Hemorrhage
• Ischemia
• Neurologic deterioration including stroke progression, stroke in new vascular territory, and death
• Perforation or dissection of the vessel
• Persistent neurological deficits
• Post procedure bleeding
• Pseudo aneurysm formation
• The risk of complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia) increases as the procedure time and the number of procedures increase
• Thrombosis (acute and subacute)
• Vascular occlusion
• Vasoconstriction (Vasospasm)

WARNINGS

• The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
• Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Do not cause delays in this therapy.
• Do not torque the Solitaire™ X Revascularisation Device.
• For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire™ X Revascularisation Devices.
• For device safety, do not use each Solitaire™ X Revascularisation Device for more than three flow restoration recoveries.
• For each new Solitaire™ X Revascularisation Device, use a new microcatheter.
• Solitaire™ X Revascularisation Device does not allow for electrolytic detachment.
• To prevent device separation:
      - Do not oversize device.
      - Do not recover (i.e. pull back) the device when encountering excessive resistance. Instead, resheath the device with the microcatheter and then remove the entire system under aspiration. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration.
      - Do not treat patients with known stenosis proximal to the thrombus site.
• This device is supplied STERILE for single use only. Do not reprocess or re-sterilise. Reprocessing and re-sterilisation increase the risks of patient infection and compromised device performance.
• If excessive resistance is encountered during the delivery of the Solitaire™ X Revascularisation Device, discontinue the delivery and identify the cause of the resistance. Advancement of the Solitaire™ X Revascularisaton Device against resistance may result in nerve damage and/or patient injury.
• Advancing the microcatheter while the device is engaged in clot may lead to embolisation of debris.
• Do not advance the microcatheter against any resistance.
• Do not reposition more than two times.
• If excessive resistance is encountered during recovery of the Solitaire™ X Revascularisation Device, discontinue the recovery and identify the cause of the resistance.
• For vessel safety, do not perform more than three recovery attempts in the same vessel using the Solitaire™ X Revascularisation Device.
• For device safety, do not use each Solitaire™ X Revascularisation Device for more than three flow restoration recoveries.