Resources.

The i-ED COIL must not be used in:

1. Patients with serious thrombocytopenia or abnormal disability in blood coagulation, for whom uncontrollable bleedings resulting in life-threatening consequences may occur during the procedures to place the coil.

2. Patients with a medical history of hypersensitivity to platinum and/or tungsten.

3. Patients with a pacemaker because electrical noises generated during the use of the i-ED COIL may cause malfunctions of the pacemaker resulting in life-threatening consequences.

4. Patients with an implantable cardioverter defibrillator (ICD), because electrical noises generated during the use of the i-ED COIL may cause malfunctions of the ICD resulting in life threatening consequences.

5. Embolization of a dissecting aortic aneurysm. In the event that a major bleeding occurs, it may result in the patient’s death.

For single use only. Do not re-use. Do not resterilize. Re-use, 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. Re-use, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, 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.

2. Do not use the i-ED COIL if the device itself or its packaging is found damaged or to have any abnormality. (A damaged i-ED COIL may cause vascular injury or unexpected movement of the distal end of the coil during its placement. It also may affect stability during insertion or after placement and may cause migration or unraveling of the coil.)

3. Do not use the product after the “Use-by” date specified on the product label.

4. The i-ED COIL was designed and tested for use with the EDG v4. Do not use other detachment devices with the i-ED COIL as this may pose risks to patient safety.

1. If the contrast media was infused from the microcatheter, ensure to flush out the contrast media with heparinized physiological saline solution (hereinafter referred to as “heparinized saline”) with at least 2-fold of the dead space volume of the lumen of the microcatheter. The residual contrast media, if any, inside the microcatheter lumen may delay swelling of the PVA rod.

2. Do not use this product that is once took out and put into the sheath again. Doing so may cause damage on the cover of the pusher and lead to insertion failure.

3. If any resistance is felt while advancing the pusher in the sheath or in the microcatheter, do not advance it forcibly. Identify the cause of resistance and remove the i-ED COIL together with the microcatheter, if necessary, out of the patient.

4. All procedures must be performed under aseptic conditions.

5. The i-ED COIL should only be used by physicians experienced in intravascular catheterization techniques and have received a prior explanation about the usage of this device, and in medical facilities where appropriate emergency measures will be available.

6. The size and number of coils to be placed should be carefully determined based on the experience of the physician.

7. The insertion and withdrawal of the i-ED COIL should be conducted gently with care so that damage to the patient’s blood vessel wall or the device itself may be prevented.

Keep the proximal end of the pusher away from wet drapes. If it occurs, conduction between the device and the patient’s body may occur and a detachment of the coil will become difficult or the green lamp of the EDG v4 may be lit even when the detachable part is still within the microcatheter.

9. If the i-ED COIL, even its part, is once inserted into and then pulled out from a microcatheter, do not insert that i-ED COIL into the microcatheter again.

10. For the delivery of the i-ED COIL into the patient, do not use a microcatheter that is used with embolization materials other than a coil. (The i-ED COIL may become stuck in the microcatheter, or foreign matters may be pushed out into the patient’s blood vessel.)

11. If the microcatheter kicks back from the position when performing embolization with a coil, do not attempt repositioning the microcatheter. If a repositioning is absolutely necessary, do it with a special care. Re-manipulation may cause migration of any placed coil into the peripheral blood vessel.

12. Immediately use the i-ED COIL after opening the sterilized package. Dispose of the device as medical waste after use.

13. Use this device carefully for patients with an implantable medical device having electrodes in the head and neck (e.g., artificial cochlear system, brain/spinal stimulation device). High frequency from this device may affect to the implantable devices.

14. Take all necessary actions to limit X-ray radiation doses to patients and users by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.

The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The i-ED COIL System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The following device failures, adverse events and complications may occur during the use of the i-ED COIL. However, device failures, adverse events and complications are not limited to those listed below. Immediately take appropriate measures in the event that any abnormality occurs.

1. Device Failures

(1) Migration of the platinum coil

(2) Breakage or unraveling of the platinum coil

(3) Detach-failure of the platinum coil

(4) Delivery failure of the platinum coil

2. Adverse Events

(1) Death

(2) Hematoma

(3) Injury to blood vessels or tissues, vessel wall dissection, blood vessel perforation, blood vessel rupture

(4) Embolization

(5) Bleeding, ischemia

(6) Angiospasm

(7) Stroke, cerebral infarction

(8) Nerve disorder

(9) Infection

(10) Shock

(11) Allergic reaction

3. Complications related to X-ray fluoroscopy

(12) Alopecia

(13) Burns ranging in severity from skin reddening to ulcers

(14) Cataracts

(15) Delayed neoplasia