Indications, safety, and warnings Acute ischemic stroke

• Solitaire™ X Revascularization Device
  
• React™ Catheter
• Phenom™ Catheter
• Riptide™ Aspiration System

Solitaire™ X Revascularization Device

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.

Caution

• Federal (USA) law restricts this device to sale by or on the order of a physician. 

Precautions

• The Solitaire™ X Revascularization 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 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.
• 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
• Angina
• Arrhythmia
• Arteriovenous fistula
• Aspiration
• Brain edema
• Cancer
• Change in mental status
• Coagulopathy
• Death
• Device(s) deformation, collapse, fracture or malfunction
• Distal embolization including to a previously uninvolved territory
• Embolism
• Fever
• Fistula
• Foreign body in patient
• Foreign body reaction
• Hemolysis
• Hemorrhage
• Hemorrhagic stroke
• Hypersensitivity
• Hypertension
• Hypotension
• Infarction, cerebral
• Infection
• Inflammation
• Ischemia
• Myocardial Infarction
• Necrosis
• Nerve damage
• Neurologic deterioration including stroke progression, stroke in new vascular territory, and death
• Organ failure
• Pain
• Perforation or dissection of the vessel
• Persistent neurological deficits
• Radiation exposure, unintended
• Rupture
• Shock
• Stenosis
• 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
• Therapeutic response decreased
• Thromboembolism
• Thrombosis (acute and subacute)
• Toxicity
• User experiences major dissatisfaction with device performance
• Vascular occlusion
• Vasoconstriction (Vasospasm)
• Vision symptoms

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 and 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)

Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use.

React™ Catheter

Indications for use

The React™ 68 Catheter and React™ 71 Catheter are indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Precautions

• Do not use open, kinked, or damaged devices.
• Do not autoclave.
• Use the catheter in conjunction with fluoroscopic visualization.
• Inspect the catheter before use to verify that its size and condition are suitable for the specific procedure.
• Do not advance or withdraw the catheter against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Moving or torqueing the device against resistance may result in damage to the vessel or device.
• Maintain a constant infusion of appropriate flush solution.
• If flow through the catheter becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
• Extreme care must be taken to avoid damage to the vasculature through which the catheter passes. The catheter may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
• Torqueing the catheter may cause damage which could result in kinking and possible separation along the catheter shaft. Should the catheter become severely kinked, withdraw the catheter.
• An appropriate anticoagulation therapy should be applied per institutional guidelines.
• Operators should take all necessary precautions to limit X-radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.

Contraindications

There are no known contraindications.

Compatibility

Refer to product label for device dimensions. Refer to labeling provided with other medical technologies to determine compatibility.

Potential complications

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

• Acute occlusion
• Allergic reaction and anaphylaxis from contrast media
• Complication at puncture site
• Complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
• Embolism
• False aneurysm formation
• Infection
• Inflammation
• Intracranial hemorrhage
• Ischemia
• Neurological deficits including stroke
• Vessel spasm, thrombosis, dissection or perforation

Warnings

• The catheter should only be used by physicians who have received appropriate training in interventional techniques.
• Do not reuse. The device is intended for single use only. Discard the catheter after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning. Catheters are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.
• The catheter has not been tested for use with automated high-pressure contrast injection equipment, do not use this equipment with the device because it may damage the device.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.

Phenom™ Catheter

Indications for use

Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.

Caution

• Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician.
• This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

• Pain at insertion site
• Hematoma
• Hemorrhage
• Infection
• Sensitization or an allergic reaction
• Complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
• Distal emboli (air, foreign material or thrombus)
• Vessel spasm, dissection, perforation or injury
• Ischemia
• Stroke that could lead to Neurological deficit and death

1. THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. Discard after one procedure. Reuse and/or re-sterilization can potentially result in compromised device performance and cross contamination.
2. The Phenom™ Catheter should be manipulated under fluoroscopy only. Do not attempt to move the catheter without observing the resultant tip response.
   
3. Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the catheter against resistance may result in damage to the catheter, or the vessel.
4. The infusion pressure should not exceed the listed pressure as indicated in Flow Rate Table (listed in IFU).
5. Nickel (CAS 7440-02-0) is present in the Phenom™ Catheter and may cause sensitization or an allergic reaction.
6. The catheter has not been tested for use with automated high-pressure contrast injection equipment, do not use this equipment with the device because it may damage the device.
7. Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use the device if breaches in sterile barrier system integrity are evident.
8. For additional Materials of Concerns information such as REACH, CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship.
9. Do not use catheters that are damaged in any way. Damaged catheters may break or rupture causing vessel damage or tip detachment during the procedure.
10. Shaping mandrel is not for in-vivo use.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.

Riptide™ Aspiration System

Indications for use

The Riptide™ aspiration system is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.  

Description

The Riptide™ Aspiration System is comprised of the following devices:

• React™ 68 catheter REACT-68
• React™ 71 catheter REACT-71
• Riptide™ large bore aspiration tubing MAT-110-110
• Riptide™ aspiration pump MAP-1000
• Riptide™ collection canister with intermediate tubing MAC-1200

The Riptide™ aspiration system is designed to remove occlusive thrombus from the cerebral vasculature using continuous aspiration. The catheter shaft has a hydrophilic coating that spans the distal 40 cm to reduce friction during use. The catheter acts as a conduit for providing direct aspiration to the occlusion site generated by the Riptide™ aspiration pump. The catheter is introduced through a guide catheter or sheath and into the intracranial vasculature and guided over a neurovascular guidewire and/or microcatheter to the site of the primary occlusion. The catheter is connected to the Riptide™ aspiration pump through the aspiration tubing. The intermediate tubing connects the Riptide™ collection canister to the Riptide™ aspiration pump. The Riptide™ aspiration system in this configuration may be used to aspirate thrombus from the occluded vessel.

Note: The catheter and aspiration tubing are applied parts.

Precautions

• The catheter and the aspiration tubing are supplied sterile and are intended for single use only. Do not resterilize or re-use. Resterilization and/or re-use may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target neuro vasculature location. 
• Use the catheter, aspiration tubing, and Riptide™ Collection Canister with Intermediate Tubing prior to the “Use-by date”.
• The Riptide™ Aspiration Pump and Riptide™ Collection Canister with Intermediate Tubing are supplied non-sterile and are intended for use outside of the sterile field only.
• The Riptide™ Collection Canister with Intermediate Tubing is intended for single use only. Dispose in accordance with standard biologic waste disposal procedures.
• Do not use kinked or damaged devices. Do not use open or damaged packages.
• Inspect the catheter before use to verify that its size and condition are suitable for the specific procedure.
• Use the catheter under fluoroscopic guidance to confirm placement of the catheter proximal to the thrombus prior to applying aspiration.
• Maintain a constant infusion of appropriate flush solution.
• When performing aspiration, ensure that the aspiration tubing flow switch is in the open position for only the minimum time needed to remove thrombus.
• The recommended continuous duration of aspiration is a maximum of 90 seconds.
• If repositioning of the catheter is necessary during the revascularization procedure, such reposition should be performed over an appropriate neurovascular guidewire and/or microcatheter using standard techniques.
• Do not use automated high-pressure contrast injection equipment with the catheter because it may damage the device.
• Medical management and post stroke care should follow AHA/ASA guidelines and institutional protocols.
• As in all surgical interventions, monitoring of intra-procedural blood loss is recommended so that appropriate management may be instituted.
• Possible malfunctions of the Riptide™ Aspiration System include, but are not limited to, issues associated with vacuum for the aspiration tubing, Riptide™ Aspiration Pump, and Riptide™ Collection Canister with Intermediate Tubing that may lead to decreased therapeutic response during mechanical thrombectomy.
• Operators should take all necessary precautions to limit X-radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.

Contraindications

There are no known contraindications.

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:

• Acute occlusion
• Allergic reaction and anaphylaxis from contrast media
• Arrhythmia
• Complication at puncture site
• Complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
• Death
• Decreased therapeutic response
• Embolism
• Fistula
• Foreign body in patient
• Hypertension/hypotension
• Infection
• Inflammation
• Intracranial hemorrhage
• Ischemia
• Nerve damage
• Neurological deficits including stroke
• Organ failure/shock
• Pain
• Stenosis
• Vessel spasm, thrombosis, dissection, or perforation

Warnings

• The Riptide™ Aspiration System should only be used by physicians who have received appropriate training in interventional neuro-endovascular techniques for treatment of acute ischemic stroke. The Riptide™ Aspiration System is designed for setup by clinical support staff under the supervision of a trained physician.
• Do not advance, retrieve, or use any component of the Riptide™ Aspiration System against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device or system as a unit. Unrestrained torquing or forced insertion of the catheter against resistance may result in damage to the device or vessel.
• For vessel safety, do not perform more than three attempts at aspiration in the same vessel using the Riptide™ Aspiration System.
• Do not use devices in conjunction with or in place of those devices specified above when using the Riptide™ Aspiration System.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.