Solitaire X Revascularization Device INDICATIONS, SAFETY, AND WARNINGS

INDICATIONS FOR USE

  1. The Solitaire™ X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
  2. The Solitaire™ X Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
  3. The Solitaire™ X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (<70 cc by CTA or MRA, <25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

CAUTIONS

  • CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals.

PRECAUTIONS

  • The Solitaire™ X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.
  • Carefully inspect the sterile package and the Solitaire™ X Revascularization Device prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.
  • The Solitaire™ X Revascularization 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 labeling for indications, contraindications, warnings, precautions, and instructions for use.
  • 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.
  • Initiate mechanical thrombectomy treatment as soon as possible.
  • For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset.
  • For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size.

CONTRAINDICATIONS

Use of the Solitaire™ X Revascularization 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 Revascularization Device.
  • Patients with angiographic evidence of carotid dissection.

 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 embolization 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 — ALL INDICATIONS

  • 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.
    • Per IV t-PA manufacturer labeling, IV t-PA should be administered within 3 hours of stroke symptom onset (IV t-PA use beyond 3 hours is not approved in the United States).
  • Do not torque the Solitaire™ X Revascularization Device.
  • For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire™ X Revascularization Devices.
  • For device safety, do not use each Solitaire™ X Revascularization Device for more than three flow restoration recoveries.
  • For each new Solitaire™ X Revascularization Device, use a new microcatheter.
  • Solitaire™ X Revascularization 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-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance.
  • If excessive resistance is encountered during the delivery of the Solitaire™ X Revascularization Device, discontinue the delivery and identify the cause of the resistance. Advancement of the Solitaire™ X Revascularizaton Device against resistance may result in device damage and/or patient injury.
  • If excessive resistance is encountered during recovery of the Solitaire™ X Revascularization Device, discontinue the recovery and identify the cause of the resistance.
  • Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris.
  • Do not advance the microcatheter against any resistance.
  • Do not reposition more than two times.

WARNINGS — INDICATION 1 & 3 ONLY

  • The safety and effectiveness has not been established for the Solitaire™ X device to reduce disability in patients with the following:
    • Posterior circulation occlusions
    • More distal occlusions in the anterior circulation
    • Large core infarct (ASPECTS ≤7)