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PD030003 Rev. A 3 MicroVention, Inc.

35. At the end of the detachment cycle, three audible tones will sound and the

light will ﬂash yellow three times. This indicates that the detachment cycle is

complete. If the coil does not detach during the detachment cycle, leave the

V-Grip

detachment controller attached to the V-Trak

delivery pusher and

attempt another detachment cycle when the light turns green.

36. The light will turn red after the number of detachment cycles speciﬁed on the

V-Grip

labeling. DO NOT use the V-Grip

detachment controller if the light

is red. Discard the V-Grip

detachment controller and replace it with a new one

when the light is red.

37. Verify detachment of the coil by ﬁrst loosening the RHV valve, then pulling back

slowly on the delivery system and verifying that there is no coil movement. If the

implant did not detach, do not attempt to detach it more than two additional

times. If it does not detach after the third attempt, remove the delivery system.

38. After detachment has been conﬁrmed, slowly retract and remove the delivery

pusher. Advancing the V-Trak

delivery pusher once the coil has been

detached involves risk of aneurysm or vessel rupture. Do NOT advance the

delivery pusher once the coil has been detached.

39. Verify the position of the coil angiographically through the guide catheter.

40. Prior to removing the microcatheter from the treatment site, place an

appropriately sized guidewire completely through the microcatheter lumen to

ensure that no part of the coil remains within the microcatheter.

The physician has the discretion to modify the coil deployment technique to

accommodate the complexity and variation in embolization procedures. Any technique

modiﬁcations must be consistent with the previously described procedures, warnings,

precautions and patient safety information.

SPECIFICATIONS FOR V-GRIP

DETACHMENT CONTROLLER

• Output voltage: 8 ± 1 VDC

• Cleaning, preventative inspection, and maintenance: The V-Grip

detachment

controller is a single use device, preloaded with battery power, and packaged

sterile. No cleaning, inspection, or maintenance is required. If the device does not

perform as described in the Detachment section of these Instructions, discard the

V-Grip

detachment controller and replace it with a new unit.

• The V-Grip

detachment controller is a single use device. It should not be cleaned,

re-sterilized, or re-used.

• Batteries are pre-loaded into the V-Grip

detachment controllers. Do not attempt

to remove or replace the batteries prior to use.

• After use, dispose of the V-Grip

detachment controller in a manner consistent

with local regulations.

PACKAGING AND STORAGE

The MCS is placed inside a protective, plastic dispenser hoop and packaged in a

pouch and unit carton. The MCS and dispenser hoop will remain sterile unless the

package is opened, damaged, or the expiration date has passed. Store at a controlled

room temperature in a dry place.

The V-Grip

detachment controller is packaged separately in a protective pouch and

carton. The V-Grip

detachment controller has been sterilized; it will remain sterile

unless the pouch is opened, damaged, or the expiration date has passed. Store at a

controlled room temperature in a dry place.

SHELF LIFE

See the product label for the device shelf life. Do not use the device beyond the

labeled shelf life.

MR INFORMATION

The MicroPlex Coil System (MCS) implant has been determined to be MR conditional

according to the terminology speciﬁed in the American Society for Testing and

Materials (ASTM) International, Designation: F2503-08.

Non-clinical testing demonstrated that the MCS implant is MR conditional. A patient

can be scanned safely, immediately after placement under the following conditions:

• Static magnetic ﬁeld of 3 Tesla or less

• Maximum spatial gradient ﬁeld of 720 Gauss/cm or less

MRI-Related Heating

In non-clinical testing, the MCS implant produced a maximum temperature rise of 1.6°C

during MRI performed for 15 minutes of scanning in the 3 Tesla (3-Tesla/128-MHz,

Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR system.

Therefore, the MRI-related heating experiments for the MCS implant at 3 Tesla using

a transmit/receive RF body coil at an MR system reported whole body averaged SAR

of 2.9 W/kg (i.e., associated with a calorimetry measured whole body averaged value

of 2.7 W/kg) indicated that the greatest amount of heating that occurred in association

with these speciﬁc conditions was equal to or less than 1.6°C.

Image Artifact Information

MR image quality may be compromised if the area of interest is in the exact same area

or relatively close to the position of the MCS implant. Therefore, optimization of MR

imaging parameters to compensate for the presence of this device may be necessary.

of the coil into the aneurysm. Rotating the MCS V-Trak

delivery pusher may

result in a stretched coil or premature detachment of the coil from the V-Trak

delivery pusher, which could result in coil migration. Angiographic assessment

should also be performed prior to detachment to ensure that the coil mass is not

protruding into the parent vessel.

25. Advance the coil into the desired site until the radiopaque proximal marker on

the delivery system is aligned with the proximal marker on the microcatheter as

shown.

MICROCATHETER

IMPLANT

DISTAL END OF V-TRAK

DELIVERY PUSHER

PROXIMAL MARKER

26. Tighten the RHV to prevent movement of the coil.

27. Verify repeatedly that the distal shaft of the V-Trak

delivery pusher is not under

stress before coil detachment. Axial compression or tension could cause the tip

of the microcatheter to move during coil delivery. Catheter tip movement could

cause the aneurysm or vessel to rupture.

DETACHMENT OF THE MCS COIL

28. The V-Grip

detachment controller is pre-loaded with battery power and will

activate when a MicroVention V-Trak

delivery pusher is properly connected.

It is not necessary to push the button on the side of the V-Grip

detachment

controller to activate it.

29. Verify that the RHV is ﬁrmly locked around the V-Trak

delivery pusher before

attaching the V-Grip

detachment controller to ensure that the coil does not

move during the connection process.

30. Although the V-Trak

delivery pusher’s gold connectors are designed to be

compatible with blood and contrast, every effort should be made to keep the

connectors free of these items. If there appears to be blood or contrast on

the connectors, wipe the connectors with sterile water before connecting the

V-Grip

detachment controller.

31. Connect the proximal end of the V-Trak

delivery pusher to the V-Grip

detachment controller by ﬁrmly inserting the proximal end of the V-Trak

delivery

pusher into the funnel section of the V-Grip

detachment controller.

V-Grip

Detachment Controller

32. When the V-Grip

detachment controller is properly connected to the V-Trak

delivery pusher, a single audible tone will sound and the light will turn green to

signal that it is ready to detach the coil. If the detachment button is not pushed

within 30 seconds, the solid green light will slowly ﬂash green. Both ﬂashing

green and solid green lights indicate that the device is ready to detach. If the

green light does not appear, check to ensure that the connection has been

made. If the connection is correct and no green light appears, replace the

V-Grip

detachment controller.

33. Verify the coil position before pushing the detachment button.

34. Push the detachment button. When the button is pushed, an audible tone will

sound and the light will ﬂash green.

Insert Direction

Funnel

Detachment Button

Light

V-Trak

delivery

pusher

Brand	Terumo
Model	MicroVention MicroPlex Coil System Series
Category	Medical Equipment
Language	English

Terumo MicroVention MicroPlex Coil System Series User Manual

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Terumo MicroVention MicroPlex Coil System Series Specifications

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