Axium™ and Axium™ Prime Detachable Coils Indications, Safety, and Warnings

INDICATIONS FOR USE

AXIUM™ Detachable Coils and AXIUM™ PRIME Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. AXIUM™ Detachable Coils and AXIUM™ PRIME Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

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 with a thorough understanding of angiography and percutaneous neurointerventional procedures.

PRECAUTIONS

• Handle the AXIUM™ Detachable Coil or the AXIUM™ PRIME Detachable Coil with care to avoid damage before or during treatment.
• Do not advance the AXIUM™ Detachable Coil or the AXIUM™ PRIME Detachable Coil  against a noted resistance until the cause of the resistance is cleared by fluoroscopy. This may lead to the destruction of the coil and/or catheter or perforation of the vessel. 
• It is essential to confirm catheter compatibility with the AXIUM™ Detachable Coil or the AXIUM™ PRIME Detachable Coil. The outer diameter of the AXIUM™ Detachable Coil or the AXIUM™ PRIME Detachable Coil should be checked to ensure that the coil will not block the catheter.
  
• The dispenser track, introducer sheath and the I.D. (Instant Detacher) are not intended to make contact within the patient.
  
• Do not use the AXIUM™ Detachable Coil or the AXIUM™ PRIME Detachable Coil and I.D. (Instant Detacher) after the expiration date printed on the product label.
  
• In order to achieve optimal performance of the AXIUM™ Detachable Coil or of the AXIUM™ PRIME Detachable Coil and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained.
  
• Advance and retract AXIUM™ Detachable Coils or AXIUM™ PRIME Detachable Coil  slowly and smoothly, especially in tortuous anatomy. Remove the coil if unusual friction or “scratching” is noted. If friction is noted in a second coil, carefully examine both the coil and the catheter for possible damage such as catheter shaft buckling or kinking, or an improperly fused joint.
  
• If delivery pusher buckling or kinking is noted, grasp the distal most portion of the delivery pusher, distal to the kink, buckle or break and remove from microcatheter.
  
• Do not advance the coil with force if the coil becomes lodged within or outside the microcatheter. Determine the cause of resistance and remove the system when necessary.
  
• If resistance is encountered when withdrawing the implant delivery pusher, draw back on the infusion catheter simultaneously until the delivery pusher can be removed without resistance.
  
• If resistance is noted during coil delivery, remove the system and check for possible damage to the catheter.

COMPATIBILITY

The following devices are required for use with the Axium™ Detachable Coil:

DIAGNOSTIC MR IMAGING

Non-clinical testing has demonstrated that AXIUM™ Detachable Coils and AXIUM™
PRIME Detachable Coils are MR Conditional. AXIUM™ Detachable Coils and AXIUM™
PRIME Detachable Coils can be scanned safely under the following conditions:

• Static magnetic field of 3-Tesla or less
• Spatial gradient field of 720 Gauss/cm or less
• Maximum averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

 In non-clinical testing, the AXIUM™ Detachable Coils produced a temperature rise of 0.6°C at a maximum averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3-Tesla MR scanner system (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI).

POTENTIAL COMPLICATIONS

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

• Puncture site hematoma
• Vessel perforation
• Vasospasm
• Hemorrhage
• Thromboembolic episodes
• Neurological deficits including stroke and death
• Vascular thrombosis
• Ischemia

WARNINGS

• The AXIUM™ Detachable Coil and the AXIUM™ PRIME Detachable Coil, the dispenser track, and the introducer sheath are supplied in a sterile and non-pyrogenic, unopened and undamaged package. The package should be checked for potential damage. Damaged AXIUM™ Detachable Coils or damaged AXIUM™ PRIME Detachable Coils must not be used, as they may result in patient injury.
• AXIUM™ Detachable Coils and AXIUM™ PRIME Detachable Coils are intended for one use only. The I.D. (Instant Detacher) is supplied sterile and intended for single patient use. After use do not resterilize and/or 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.
• Do not use if sterile packaging has been compromised or damaged.
• Damaged implant delivery pusher and/or coils may affect coil delivery to, and stability inside, the vessel or aneurysm, possibly resulting in coil migration or stretching. 
• Do not rotate the implant delivery pusher during or after delivery of the coil into the aneurysm. Rotating the delivery pusher during or after coil delivery into the aneurysm may result in a stretched coil or premature detachment of the coil from the implant delivery pusher, which could result in coil migration. 
• Do not use hemostats in an attempt to advance delivery pusher. This may result in a kinked pusher which may lead to premature detachment.
• Verify that the distal shaft of the microcatheter is not under stress before AXIUM™ Detachable Coil detachment or the AXIUM™ PRIME Detachable Coil detachment. Axial compression or tensile forces could be stored in the microcatheter causing the tip to move during AXIUM™ Detachable Coil delivery or during AXIUM™ PRIME Detachable Coil delivery. Microcatheter tip movement could cause the aneurysm or vessel to rupture.
• Advancing the delivery pusher beyond the microcatheter tip once the coil has been deployed and detached involves risk of aneurysm or vessel perforation.
• If undesirable movement of the AXIUM™ Detachable Coil or the AXIUM™ PRIME Detachable Coil can be seen under fluoroscopy following coil placement and prior to detachment, remove the coil and replace with another more appropriately sized AXIUM™ Detachable Coil or AXIUM™ PRIME Detachable Coil. Movement of the coil may indicate the coil could migrate once it is detached. Angiographic controls should also be performed prior to detachment to ensure that the coil mass is not protruding into the parent vessel.
• High quality, digital subtraction fluoroscopic road mapping is mandatory to achieve safe catheterization of the aneurysm or vessel and correct placement of the first coil. With smaller aneurysms this is a particularly important step.
• If AXIUM™ Detachable Coil or AXIUM™ PRIME Detachable Coil repositioning is necessary, take special care to retract coil under fluoroscopy in a one-to-one motion with the implant pusher. If the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break. Gently remove and discard both the catheter and coil.
• Due to the delicate nature of the AXIUM™ Detachable Coil and the AXIUM™ PRIME Detachable Coil, the tortuous vascular pathways that lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential malfunctions such as coil breakage and migration.
• If resistance is encountered while withdrawing an AXIUM™ Detachable Coil or an AXIUM™ PRIME Detachable Coil, which is at an acute angle relative to the catheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at the ostium of the aneurysm, or just slightly inside the parent artery.
• Take care not to puncture gloves or sterile drape while handling implant delivery pusher.
• Multiple placements of AXIUM™ Detachable Coils or AXIUM™ PRIME Detachable Coils may be required to achieve the desired occlusion of some aneurysms or vessels.
• The long term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space.
• 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.
• For Axium™ Detachable Coils: Do not use the product if the temperature indicator on either the pouch or the carton box is red. A red indicator means the product has been exposed to temperature greater than 50° C (122° F). Use of the product which has been exposed to temperature greater than 50° C (122° F), may compromise patient safety.