PD030003 Rev. A
1
MicroVention, Inc.
English
MicroPlex
®
Coil System (MCS)
Endovascular Embolization Coil
Instructions for Use
DEVICE DESCRIPTION
The MicroVention MicroPlex Coil System (MCS) consists of an implantable coil
attached to a delivery system called a V-Trak
®
delivery pusher. The V-Trak
®
delivery
pusher is powered by a V-Grip
®
detachment controller designed specifically for the
MCS. The V-Grip
®
detachment controller is provided separately.
MCS complex coils establish the initial framework in the treatment of the
cerebrovascular aneurysm or lesion. Once the initial framework has been established
by one or more complex framing coils, additional MCS complex and helical coils
provide filling of the cerebrovascular aneurysm or lesion.
The MCS is available in several coil types based on the coil primary diameter and
configuration (complex and helical). Within each coil type is a broad range of coil
secondary (loop) diameters and lengths to meet the needs of the physician. These coil
types include 10 and 18 compatible systems and are delivered through the following
wire-reinforced microcatheters with the specified minimum ID:
Table 1
Coil Type
Minimum
Microcatheter I.D.
inches
mm
MCS-18 Complex coils (except Cosmos),
13 mm or larger
0.0180
0.46
All other MicroPlex Coil System models
0.0165
0.42
INDICATIONS FOR USE
The MicroPlex Coil System (MCS) is intended for the endovascular embolization of
intracranial aneurysms and other neurovascular abnormalities such as arteriovenous
malformations and arteriovenous fistulae. The MCS 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 device should only be used by physicians who have undergone pre-clinical
training in all aspects of MCS procedures as prescribed by MicroVention.
POTENTIAL COMPLICATIONS
Potential complications include, but are not limited to: hematoma at the site of entry,
vessel perforation, aneurysm rupture, parent artery occlusion, incomplete aneurysm
filling, emboli, hemorrhage, ischemia, vasospasm, coil migration or misplacement,
premature or difficult coil detachment, clot formation, revascularization, post-
embolization syndrome, and neurological deficits including stroke and possibly death.
Cases of chemical aseptic meningitis, edema, hydrocephalus and/or headaches
have been associated with the use of embolization coils in the treatment of large and
giant aneurysms. The physician should be aware of these complications and instruct
patients when indicated. Appropriate patient management should be considered.
REQUIRED ADDITIONAL ITEMS
• MicroVention V-Grip
®
detachment controller
• Wire-reinforced microcatheter with 2 tip RO markers, appropriately sized
• Guide catheter compatible with microcatheter
• Steerable guidewires compatible with microcatheter
• 2 rotating hemostatic Y valves (RHV)
• 1 three-way stopcock
• Sterile saline
• Pressurized sterile saline drip
• 1 one-way stopcock
WARNINGS AND PRECAUTIONS
Federal law (USA) restricts this device to sale by
or on the order of a physician.
• The MCS is sterile and non-pyrogenic unless the unit package is opened or
damaged.
• The MCS is intended for single use only. Do not resterilize and/or reuse the
device. After use, dispose in accordance with hospital, administrative and/or local
government policy. Do not use if the packaging is breached or damaged.
• The MCS must be delivered only through a wire-reinforced microcatheter with a
PTFE inner surface coating. Damage to the device may occur and necessitate
removal of both the MCS and microcatheter from the patient.
• High quality, digital subtraction fluoroscopic road mapping is
mandatory
to
achieve correct placement of the MCS.
• Do not advance the V-Trak
®
delivery pusher with excessive force. Determine the
cause of any unusual resistance, remove the MCS and check for damage.
• Advance and retract the MCS device slowly and smoothly. Remove the entire MCS
if excessive friction is noted. If excessive friction is noted with a second MCS,
check the microcatheter for damage or kinking.
• If repositioning is necessary, take special care to retract the coil under fluoroscopy
in a one-to-one motion with the V-Trak
®
delivery pusher. If the coil does not move
in a one-to-one motion with the V-Trak
®
delivery pusher, or if repositioning is
difficult, the coil may have become stretched and could possibly break. Gently
remove and discard the entire device.
• Due to the delicate nature of the MCS coils, 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 coil breakage and migration.
• If a coil must be retrieved from the vasculature after detachment, do not attempt to
withdraw the coil with a retrieval device, such as a snare, into the delivery catheter.
This could damage the coil and result in device separation. Remove the coil,
microcatheter, and any retrieval device from the vasculature simultaneously.
• If resistance is encountered while withdrawing a coil that is at an acute angle
relative to the microcatheter tip, it is possible to avoid coil stretching or breaking
by carefully repositioning the distal tip of the catheter at, or slightly inside, the
ostium of the aneurysm. By doing so, the aneurysm and artery act to funnel the
coil back into the microcatheter.
• Delivery of multiple MCS coils is usually required to achieve the desired occlusion
of some aneurysms or lesions. The desired procedural endpoint is angiographic
occlusion.
• 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.
• Always ensure that at least two MicroVention V-Grip
®
detachment controllers are
available before starting a MCS procedure.
• The MCS cannot be detached with any power source other than a MicroVention
V-Grip
®
detachment controller.
• Always advance an appropriately sized guidewire through the microcatheter after
detaching the coil and removing the pusher to ensure that no part of the coil
remains within the microcatheter.
• Do NOT place the V-Trak
®
delivery pusher on a bare metallic surface.
• Always handle the V-Trak
®
delivery pusher with surgical gloves.
• Do NOT use in conjunction with radio frequency (RF) devices.
CATHETERIZATION OF THE LESION
1.
Refer to the set-up diagram.
2.
Using standard interventional procedures, access the vessel with a guide
catheter. The guide catheter should have an inner diameter (ID) large enough to
allow for contrast injection while the microcatheter is in place. This will allow for
fluoroscopic road mapping during the procedure.
3.
Attach a rotating hemostatic valve (RHV) to the hub of the guiding catheter.
Attach a 3-way stopcock to the side arm of the RHV and then connect a line for
continuous infusion of flush solution.
4.
Select a microcatheter with the appropriate inner diameter. After the
microcatheter has been positioned inside the lesion, remove the guidewire.
5.
Attach a second RHV to the hub of the microcatheter. Attach a 1-way stopcock
to the sidearm of the second RHV and connect the flush solution line to the
stopcock.
6.
Open the stopcock to allow flush through microcatheter with sterile flush
solution. To minimize the risk of thromboembolic complications, it is critical that
a continuous infusion of appropriate sterile flush solution be maintained into the
guide catheter, the femoral sheath and the microcatheter.
COIL SIZE SELECTION
7.
Perform fluoroscopic road mapping.
8.
Measure and estimate the size of the lesion to be treated.
9.
Select the appropriately sized coils.
10. Correct coil selection increases MCS effectiveness and patient safety. Occlusive
efficiency is, in part, a function of compaction and overall coil mass. In order to
choose the optimum MCS coil for any given lesion, examine the pre-treatment
angiograms. The appropriate MCS coil size should be chosen based upon
angiographic assessment of the diameter of the parent vessel, aneurysm dome
and aneurysm neck. When accessing aneurysms, the diameter of the first and
second coils should never be less than the width of the aneurysm neck or the
propensity for the coils to migrate may be increased.
