English - ev3 AXIUM Instrucciones De Uso

English

Instructions for Use
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 .
DESCRIPTION
The AXIUM™ Detachable Coil consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque
positioning marker and a hand-held I . D . (Instant Detacher) which when activated detaches the coil from the delivery pusher tip . Some of the
AXIUM™ Detachable Coils are enlaced with PGLA microfilaments or Nylon microfilaments . I . D . (Instant Detacher) is sold separately .
DEVICE COMPATIBILITY
The following devices are required for use with the AXIUM™ Detachable Coil:
Type
Axium™
Bare
Detachable Coils
Axium™
PGLA
Detachable Coils
Axium™
PGLA
Detachable Coils
Axium™
Nylon
Detachable Coils
Axium™
Nylon
Detachable Coils
Other Accessory Products (required to perform a procedure)
6–8F Guide Catheter*
Microcatheter with two marker bands (see above)*
Guidewires compatible with microcatheter*
Continuous saline/heparin saline flush set*
Rotating haemostatic valves (RHV)*
3-Way stopcock*
1-Way stopcock*
IV pole*
Femoral Sheath*
*Not provided as part of the system; chosen based upon physician experience and preference .
INDICATIONS FOR USE
AXIUM™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms . AXIUM™ Detachable Coils are also intended
for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae .
POTENTIAL COMPLICATIONS
Potential complications include, but are not limited to:
• Puncture site hematoma
• Vessel perforation
• Vasospasm
• Hemorrage
WARNINGS
• The AXIUM™ 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 must not be
used, as they may result in patient injury .
• AXIUM™ Detachable Coils are intended for one use only . 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 . Axial compression or
tensile forces could be stored in the microcatheter causing the tip to move during AXIUM™ 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 .
Minimum micro-catheter inside
Diameter (mm)
diameter (in)
All 0 . 0 165
2 to 10 0 . 0 165
12 and above 0 . 0 20
2 to 4 0 . 0 165
5 and above 0 . 0 20
• Thromboembolic episodes
• Neurological deficits including stroke and death
• Vascular thrombosis
• Ischemia
EN
WARNINGS
• If undesirable movement of the 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™ 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 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, 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, 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 .
Detacher
• Multiple placements of AXIUM™ Detachable Coils may be required to achieve the desired occlusion of some aneurysms or vessels .
I . D . (Instant
Detacher) • 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 .
I . D . (Instant
Detacher) • 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 .
I . D . (Instant
Detacher)
PRECAUTIONS
I . D . (Instant
Detacher)
• Handle the AXIUM™ Detachable Coil with care to avoid damage before or during treatment .
• Do not advance the AXIUM™ Detachable Coil against a noted resistance until the cause of the resistance is cleared by fluoroscopy . This
I . D . (Instant
may lead to the destruction of the coil and/or catheter or perforation of the vessel .
Detacher)
• It is essential to confirm catheter compatibility with the AXIUM™ Detachable Coil . The outer diameter of the AXIUM™ 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 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 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 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 .
STORAGE
Store AXIUM™ Detachable Coils in a cool dry place .
Some of the AXIUM™ Detachable Coils are enlaced with PGLA microfilaments . Store these configurations in a cool, dry place with the maximum
storage temperature not exceeding 50°C (122°F) . A temperature indicator is located on each unit box and pouch for the PGLA configurations of
the AXIUM™ Detachable Coil . If the product has been exposed to temperatures greater than 50°C (122°F), the temperature indicator on the box
and/or pouch will change to red .
WARNING
• 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 .
PREPARATIONS FOR USE
1 . In order to achieve optimal performance of the AXIUM™ Detachable Coil and to reduce the risk of thromboembolic complication, it is
advised that a continuous saline flush be maintained between a) the femoral sheath and the guiding catheter, b) the microcatheter and
guiding catheter and c) the microcatheter and the implant delivery pusher and the AXIUM™ Detachable Coil .
2 . Place the appropriate guiding catheter following recommended procedures . Connect a rotating haemostatic valve (RHV) to the hub of
the guiding catheter . Attach a 3-way stopcock to the side arm of the RHV, then connect a line for the continuous flush .
3 . Attach a second RHV to the hub of the microcatheter . Attach a 1-way stopcock to the side arm of the RHV, then connect a line for
continuous flush .
For AXIUM™ Detachable Coils: One drop from the pressure bag every 3-5 seconds is suggested .
For PGLA or Nylon microfilament AXIUM™ Detachable Coils: One drop from the pressure bag every 1-3 seconds is suggested .
4 . Check all fittings so that air is not introduced into guiding catheter or microcatheter during continuous flush .
DIAGNOSTIC MR IMAGING
Non-clinical testing has demonstrated that AXIUM™ Detachable Coils are MR Conditional . AXIUM™ 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) .
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