MicroVention, Inc. 2 PD030003 Rev. A
PREPARATION OF THE MCS FOR DELIVERY
11. Remove the V-Grip
®
detachment controller from its protective packaging. Pull
the white pull-tab from the side of the detachment controller. Discard the pull-tab
and place the detachment controller in the sterile field. The V-Grip
®
detachment
controller is packaged separately as a sterile device. Do not use any power
source other than the MicroVention V-Grip
®
detachment controller to
detach the coil. The V-Grip
®
detachment controller is intended to be used
on one patient. Do not attempt to re-sterilize or otherwise re-use the
V-Grip
®
detachment controller.
12. Prior to using the device, remove the proximal end of the V-Trak
®
delivery pusher
from the packaging hoop. Use care to avoid contaminating this end of the
delivery pusher with foreign substances such as blood or contrast. Firmly insert
the proximal end of the delivery pusher into the funnel section of the V-Grip
®
detachment controller. Do not push the detachment button at this time.
13. Wait three seconds and observe the indicator light on the detachment controller.
• If the green light does not appear or if a red light appears, replace the device.
• If the light turns green, then turns off at any time during the three-second
observation, replace the device.
• If the green light remains solid green for the entire three-second observation,
continue using the device.
14. Remove the MCS from the packaging hoop by pulling the proximal end until the
introducer exits the hoop.
15. Hold the device just distal to the shrink-lock and pull the shrink-lock proximally
to expose the tab on introducer sheath.
Pull Shrink-Lock Proximally
16. Slowly advance the MCS implant out of the introducer sheath and inspect the
coil for any irregularities or damage. If any damage to the coil or V-Trak
®
delivery pusher is observed, DO NOT use the system.
17. While holding the introducer sheath vertically, gently retract the coil back into the
introducer sheath about 1 to 2 cm.
INTRODUCTION AND DEPLOYMENT OF THE MCS
18. Open the RHV on the microcatheter just enough to accept the introducer sheath
of the MCS.
19. Insert the introducer sheath of the MCS through the RHV. Flush the introducer until
it is completely purged of air and saline flush exits the proximal end.
20. Seat the distal tip of the introducer sheath at the distal end of the microcatheter
hub and close the RHV lightly around the introducer sheath to secure the RHV to
the introducer.
Do not over-tighten the RHV around the introducer sheath. Excessive
tightening could damage the device.
21. Push the coil into the lumen of the microcatheter. Use caution to avoid catching
the coil on the junction between the introducer sheath and the hub of the
microcatheter.
22. Push the MCS through the microcatheter until the proximal end of the V-Trak
®
delivery pusher meets the proximal end of the introducer sheath. Loosen the
RHV. Retract the introducer sheath just out of the RHV. Close the RHV around
the V-Trak
®
delivery pusher. Slide the introducer sheath completely off of the
V-Trak
®
delivery pusher. Use care not to kink the delivery system.
23. Carefully advance the MCS until the coil exit marker on the proximal end of the
V-Trak
®
delivery pusher approaches the RHV on the hub of the microcatheter. At
this time, fluoroscopic guidance must be initiated.
V-Trak
®
Delivery Pusher and Coil Exit Marker
24. Under fluoroscopic guidance, slowly advance the MCS coil out the tip of
the microcatheter. Continue to advance the MCS coil into the lesion until
optimal deployment is achieved. Reposition if necessary. If the coil size is not
suitable, remove and replace with another device. If undesirable movement
of the coil is observed under fluoroscopy following placement and prior to
detachment, remove the coil and replace with another more appropriately sized
coil. Movement of the coil may indicate that the coil could migrate once it is
detached. DO NOT rotate the V-Trak
®
delivery pusher during or after delivery
Diagram of MCS Setup
Line to flush solution
V-Trak
®
delivery pusher
proximal end connects to V-Grip
®
detachment controller
RHV
Introducer sheath stop point
3-way stopcock
Guide catheter
Femoral sheath
3-cm RO marker band
Microcatheter
MCS coil
One-way stopcock
Line to flush solution
Line to flush
solution
3-way stopcock
Aneurysm
Microcatheter RO marker band
Tab on introducer sheath
Pull shrink-lock proximally
{
RHV
V-Trak
®
delivery pusher
Coil Exit Marker
Microcatheter hub
RHV
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