Indications, safety, and warnings Axium™ and Axium™ Prime detachable coils

INDICATIONS FOR USE

Axium™ and Axium™ Prime detachable coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ and Axium™ Prime detachable coils are also intended for the embolization of other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Axium™ Prime (Frame) detachable coils are also indicated for arterial and venous embolizations in the peripheral vasculature.

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to:

• Access site complications such as vessel occlusion, intimal damage, pseudo aneurysm, arteriovenous fistula, necrosis, pain, infection, inflammation, granuloma, hematoma, nerve damage, or pathological hand cold intolerance
• Complications of radiation exposure such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia
• Hemorrhage
• Ischemia
• Neurological deficits including hand dysfunction, stroke, and death
• Thromboembolic episodes
• Vascular thrombosis
• Vasospasm
• Vessel perforation

WARNINGS

• The Axium™ or Axium™ Prime Detachable Coil, the dispenser track, and the introducer sheath are supplied in a sterile and nonpyrogenic, unopened and undamaged package. The package should be checked for potential damage. Damaged Axium™ and Axium™ Prime Detachable Coils must not be used, as they may result in patient injury.
• The Axium™ and Axium™ Prime Detachable Coils are intended for one use only. The instant detacher (I.D.) 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.
• Verify that the distal shaft of the microcatheter is not under stress before the Axium™ or Axium™ Prime Detachable Coil detachment. Axial compression or tensile forces could be stored in the microcatheter causing the tip to move during the Axium™ or 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™ or Axium™ 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™ 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™ 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™ and 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™ or 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™ 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.
• The safety and effectiveness of this device for radial neurovasculature access in direct comparison to a transfemoral approach has not been demonstrated. The risks and benefits for radial access against a transfemoral approach should be carefully weighed and considered for each patient.
• Do not use hemostats or a torquer in an attempt to advance delivery pusher. This may result in a kinked pusher which may lead to premature detachment.
  • If attempt to detach fails, remove coil from treatment area and microcatheter and replace with a new AXIUM™ PRIME Detachable Coil.
  • If coil becomes prematurely detached, remove implant pusher and:
    • Advance next coil to push remaining tail of prematurely detached coil into treatment area
    • Remove prematurely detached coil with the appropriate retrieval device
• Do not resterilize the AXIUM™ I.D. (Instant Detacher). For Single Patient use only.
• The AXIUM™ I.D. (Instant Detacher) is intended for a maximum of 25 cycles.
• Some AXIUM™ Detachable Coils are enlaced with PGLA microfilaments. These configurations should not be used 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.