FRED™ Indications, Safety, and Warnings

Warnings and Precaution

Contraindications: Use of the FRED system is contraindicated under these circumstances: Patients in whom anticoagulant, anti-platelet therapy, or thrombolytic drugs are contraindicated. Patients with known hypersensitivity to metal such as nickel-titanium and metal jewelry. Patients with anatomy that does not permit passage or deployment of the FRED System. Patients with an active bacterial infection. Patients with a pre-existing stent in place at the target aneurysm. Patients in whom the parent vessel size does not fall within the indicated range. Patients who have not received dual anti-platelet agents prior to the procedure.

Warnings: The FRED System should only be used by physicians trained in endovascular interventional neuroradiology, radiology, neurosurgery or interventional neurology for the treatment of intracranial aneurysms or other vascular lesions. The FRED-27 system should only be delivered through a Headway 27 microcatheter and the FRED-21 system should only be delivered through a Headway 21 microcatheter. If repeated friction is encountered during FRED System delivery, verify microcatheter is not kinked or in extremely tortuous anatomy. Confirm that the microcatheter does not ovalize. Confirm that there is adequate sterile heparinized flush solution. Do not reposition the FRED System in the parent vessel without fully retrieving the device. The FRED system MUST be retrieved/resheathed into the microcatheter and re-deployed at the desired target location or removed completely from the patient. The FRED System must not be re-deployed more than three times. Do not attempt to re-position the FRED implant after deployment/detachment. Should unusual resistance be felt at any time during access or removal, the introducer/guide catheter/microcatheter and FRED System should be removed as a single unit. Applying excessive force during delivery or retrieval of the FRED System can potentially result in loss or damage to the device and delivery components. The FRED System is provided sterile for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. The FRED System delivery wire should not be utilized as a guidewire. Do not torque the FRED System. A torque device should not be used. Placement of multiple implants may increase the risk of ischemic complications. Delayed rupture may occur with large and giant intracranial aneurysms The safety and effectiveness of the device has not been established in the treatment of ruptured intracranial aneurysms. The benefits may not outweigh the risks of treatment of small and medium stable asymptomatic extradural intracranial aneurysms in patients without additional risk factors, including those located in the cavernous internal carotid artery. The risk of rupture for small and medium stable asymptomatic extradural intracranial aneurysms is very low if not negligible. A slight decrease in the proportion of patients who achieve complete aneurysm occlusion without significant parent artery stenosis has been observed with the use of the device in the communicating segment (C7) of the internal carotid artery (ICA) [52.6% (10/19)] subjects in the FRED IDE study at 1 year)), including those intracranial aneuryms (IAs) fed by the posterior circulation or have retrograde filling. Ensure appropriate patient selection and weigh the benefits and risks of alternative treatments prior to the treatment of intracranial aneurysms located in this region of the ICA. The following anatomical characteristics, associated with retrograde filling, should be carefully considered during procedural planning of C7 intracranial aneurysms: 1. Observed posterior communicating artery (PComm) of fetal origin (A posterior cerebral artery (PCA) of fetal origin is defined as a small, hypoplastic, or absent P1 segment of the PCA with the PComm artery supplying a majority of blood flow to the ICA); 2. PComm branch arising from the aneurysm neck; and/or 3. PComm branch arising from the dome of the aneurysm. DO NOT FULLY DEPLOY FRED System. DO NOT CONTINUE if any defect is observed; return the unit to Terumo Neuro. Purge the FRED System carefully to avoid the accidental introduction of air into the system. Do not torque the delivery wire while advancing or retracting the FRED System.Do not apply undue force. If resistance is encountered at any point during delivery or manipulation, withdraw the unit and select a new FRED System. Do not fully deploy the FRED System if positioning in the parent vessel is not satisfactory.

Precautions: The FRED System does not contain latex or polyvinyl chloride (PVC) materials. Carefully inspect the sterile package and the FRED System prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components, or if the package is opened or damaged. See the product label for shelf life. Do not use the FRED System beyond the labeled use by date. Exercise caution when crossing the deployed/detached FRED System with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement. Carefully weigh the benefits of treatment vs. the risks associated with treatment using the device for each individual patient based on their medical health status and risks factors for intracranial aneurysm rupture during their expected life time such as age, medical comorbidities, history of smoking, intracranial aneurysm size, location, and morphology, family history, history of prior asymptomatic subarachnoid hemorrhage (aSAH), documented growth of intracranial aneurysm on serial imaging, presence of multiple intracranial aneurysms, and presence of concurrent pathology. The benefits of device use may not outweigh the risks associated with the device in certain patients; therefore, judicious patient selection is recommended. The FRED implant may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to assess effective intracranial aneurysm treatment. 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 were possible. The safety and effectiveness of the device has not been established for treatment of fusiform IAs.

Potential Complications: Below is a list of the probable adverse effects (e.g., complications) associated with the use of neurovascular flow diverting stents. Allergic reaction, including but not limited to: contrast dye, nitinol metal, and any other medications used during the procedure. Amaurosis fugax or transient blindness. Aphasia. Blindness. Cardiac arrhythmia. Complications of arterial puncture including pain, local bleeding, or injury to the artery, or adjacent nerves. Cranial neuropathy. Death. Device fracture, migration or misplacement. Diplopia. Dissection or perforation of the parent artery. Headache. Hemiplegia. Hemorrhage, including intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), and retroperitoneal. Hydrocephalus. Infection. Mass effect Myocardial infarction. Neurological deficits. Pseudoaneurysm formation. Reactions to anti‐platelet or anti‐coagulant agents. Reactions due to radiation exposure, including alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia. Reactions to anesthesia and related procedures. Reactions to contrast agents including allergic reactions and kidney failure. Reduced visual acuity or visual field. Retinal artery occlusion or infarction. Retinal ischemia. Rupture or perforation of the aneurysm. Stenosis of stented segment. Seizure. Stent thrombosis. Stroke or TIA (transient ischemic attack). Thromboembolic event. Vasospasm. Visual impairment.