OUS TriGUARD 3™ Cerebral Embolic Protection Device Important Safety Information

Indication

The TriGUARD 3 Cerebral Embolic Protection Device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from the cerebral circulation during trans-catheter heart procedures.

Intended use
Reduce cerebral embolization during transcatheter heart procedures.

Contraindications
DO NOT USE IN THE FOLLOWING CIRCUMSTANCES:

• Hypercoagulable states that cannot be corrected by additional periprocedural heparin.
• Renal failure with plasma creatinine > 4 mg/dl.
• Hepatic failure.
• Patients with allergy to nitinol or heparin
• Patients with history of heparin-induced thrombocytopenia

Warnings

• Only physicians trained in the use of the device should use it.
• The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure to minimize the risk of embolism and thrombosis.
• Porcine material as porcine allergens other than porcine heparin could be present
• Failure to follow recommended device preparation and use of dry pad to wipe the filter may damage the hydrophilic coatings and potentially cause serious injuries to patients.
• Introduce and advance devices slowly to prevent air embolism or trauma to the vasculature.
• Do not attempt to move the handle without observing the resultant deflection-filter response.
• Visualization of device position is essential for proper deployment. In procedures where visualization of the device via fluoroscopy is impeded by patient obesity or other reasons, do not attempt to deploy the device in the aortic arch.
• Ensure visualization of the device when attempting to cross the aortic arch with any device. Uncontrolled interaction between the TriGUARD 3 Cerebral Embolic Protection Device and any other device may lead to undesirable movement of the deflection-filter, resulting in incomplete coverage of the ascending arteries.
• To avoid damage to the device or injury to the patient, do not pull excessively on the device handle or
• Rotation of the device handle may result in rotation or flipping of the device. Do not attempt to rotate or torque the device using any accessory tool or the device handle.
• Single use device do not reuse or re-sterilize. Reusing the device may impose risk of inter-patient contamination, improper cleaning and compromised performance of the device.
• In case of redeployment, first pull back the device into the sheath and then advance the sheath over the wire to the desired location. Once in the desired location, deploy per the instructions for use.
• The safety and effectiveness of the device has not been evaluated in patient populations with the following conditions:
  • Variant angina pectoris, unstable angina or recent acute coronary syndrome including myocardial infarction (in the past three months).
  • Stroke, TIA – Transient Ischemic Attack (in the past 6 months).
  • Hypotension (systolic blood pressure of below 90mm Hg).
  • Active peptic disease or history of upper GI bleeding.
  • Spastic bronchitis, Chronic Obstructive Lung Disease, Asthma.
  • Complex ventricular arrhythmia or history thereof.
  • Major psychiatric disorder in the present or past.
  • Bleeding diathesis such as hemophilia, ITP, aplastic anemia, TTP etc.
  • Diabetes mellitus with peripheral vascular and/or neurologic changes.
  • Any proliferative disease with patient lifespan less than 6 months.
  • Pregnancy.
  • Pediatric use.

Warnings

There are risks associated with any endovascular intervention and complications may develop. The following anticipated events have been identified as possible complications of trans-catheter procedures and these and others may be associated with the device:

• Acute cardiovascular surgery (need for)
• Acute coronary artery occlusion
• Acute myocardial infarction
• Acute neurological events such as: Stroke, transient ischemic attack (TIA), encephalopathy
• Allergic reaction to contrast, antiplatelet therapy or device component materials
• Angina pectoris
• Anesthesia reactions
• Aneurysm or pseudoaneurysm
• Arteriovenous fistula
• Ascending or descending aorta trauma
• Atrial or ventricular arrhythmias or fibrillation, Heart Palpitations (sustained requiring therapy)
• Bleeding complications such as hematoma and hemorrhage
• Bleeding at access site
• Blood loss requiring transfusion
• Coronary artery or other vascular injury, dissection, or perforation which may need repair
• Blue toe syndrome or blue discoloration of a toe
• Bowel ischemia
• Embolism (air, tissue, device, or thrombus)
• Fever
• Femoral nerve damage
• Fluoroscopy related harm
• Hemodynamic changes
• Hypertension or hypotension (sustained requiring therapy)
• Infection, including endocarditis and septicemia
• Pain (at femoral puncture site, abdominal, back or other)
• Percutaneous coronary intervention (need for)
• Peripheral ischemia, peripheral nerve damage
• Pulmonary edema
• Pyrogenic reaction
• Renal complications, injury, or failure
• Unstable angina
• Vascular complications which may require vessel repair
• Vessel spasm (sustained, not responding to therapy)

In addition to the risks listed above, the potential risks specifically associated with the Keystone Heart TriGUARD 3 Cerebral Embolic Protection Device procedure includes, but may not be limited to, the following:

• Dislodgement or migration of the TriGUARD 3 Cerebral Embolic Protection Device or its delivery system, due to passage of other instrumentation, e.g.: balloon, stent, catheter, wire.
• Femoral bleeding at the access site.
• Local trauma to the aortic wall due to device migration.