FRED™ X 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:

• Should unusual resistance be felt at any time during access or removal, the introducer/guide catheter/microcatheter and FRED X System should be removed as a single unit. Applying excessive force during delivery or retrieval of the FRED X System can potentially result in loss or damage to the device and delivery components.

• The FRED X 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. FRED X System Instructions for Use

• The FRED X System should only be delivered through the appropriate Headway microcatheter, Headway 27 for FRED X System sizes 3.5 - 5.5 mm and Headway 21 for FRED X System sizes 2.5 - 3.0 mm.

• If repeated friction is encountered during FRED X 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 X System in the parent vessel without fully retrieving the device. The FRED X System MUST be retrieved/resheathed into the microcatheter and re-deployed at the desired target location or removed completely from the patient.

• Do not attempt to re-position the FRED X implant after deployment/detachment.

• The safety and performance of the FRED X System for use in conjunction with intravascular medical devices other than neurovascular embolization coils have not been established.

Precautions:

• This product should only be used by experienced physicians who have completed endovascular training in the use of the FRED X System. This device is used for percutaneous neurointerventional and peripheral vascular procedures as indicated by a representative from Terumo Neuro or a Terumo Neuro-authorized distributor.

• The FRED X System does not contain latex or PVC materials.

• The FRED X 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.

• Carefully inspect the sterile package and the FRED X 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 X System beyond the labeled use by date.

• Exercise caution when crossing the deployed/detached FRED X System with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement

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.