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Instructions for Use
MVP® Micro Vascular Plug System
DEVICE DESCRIPTION
The MVP® Micro Vascular Plug System is a self-expanding vessel occlusion device. The
MVP Device is ovoid-shape, comprised of nitinol and secured at both ends with platinum
marker bands. The device incorporates a PTFE partial cover. The proximal marker band
attaches to a wire that pushes the device through a commercially available microcatheter
to the intended treatment site. The "delivery wire" detaches from the MVP Device by
mechanical means.
The MVP System is packaged as a single unit with the MVP Device, introducer sheath and
detachable delivery wire. The System is provided sterile, non-pyrogenic, and is intended
for single use only.
Figure 1: Reverse Medical MVP® Micro Vascular Plug
System
Proximal Marker
Delivery Wire
Detachment Zone
180 cm
B. Length
Table 1. MVP System Dimensions
Model A. Diameter B. Length
Unconstrained Unconstrained
MVP-3Q 5.3mm 12mm
MVP-5Q 6.5mm 12mm
Table 2. Recommended Microcatheter
Model Rec. Microcatheter ID Rec. Microcatheter Max. Length
MVP-3Q 0.021"-027" 150cm
MVP-5Q 0.027" 150cm
INDICATIONS FOR USE
The Reverse Medical Corporation MVP® Micro Vascular Plug System is indicated to obstruct or
reduce the rate of blood ow in the peripheral vasculature.
CONTRAINDICATIONS
None known.
COMPATIBILITY
Refer to product label for device dimensions. Refer to labeling provided with other medical
technologies to determine compatibility.
WARNINGS
• The safety and e ectiveness of the MVP System has not been established for cardiac
uses (e.g., cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closure)
and neurologic uses.
• The MVP System should only be used by physicians who are familiar with angiographic
and interventional procedures. It is important to read the instructions for use prior
to using this product.
• Use prior to the expiration date printed on the product packaging label.
• The MVP System is provided sterile and non-pyrogenic unless the unit package is
opened or damaged. Do not use if the packaging is breached or damaged.
• Inspect the MVP System prior to use for any irregularities or damage and discard if any
inconsistencies are observed.
• The MVP System is intended for single use only. After use dispose device in accordance
with hospital and/or local government policy. The device should not be cleaned,
re-processed, re-sterilized, or reused as these processes may damage the components
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and surface of the device and compromise performance. In addition, the risk of
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infection of a reprocessed device has not been quali ed in order to reduce this risk to
an acceptable level. Structural integrity and/or function may be impaired by reuse
or cleaning.
• The MVP System should be advanced or manipulated under uoroscopic guidance. Do
not advance or withdraw the device when excessive resistance is met until the cause
of resistance is determined.
• Do not twist or rotate the delivery wire or the device may detach prematurely.
• Do not use a power injection syringe to inject contrast solution with the device
through a microcatheter.
• Do not advance the delivery wire after detaching it from the MVP Device.
• Physicians must be prepared to deal with urgent situations which require removal of
the device. This includes the availability of an on-site surgeon.
• Do not use with catheters that are contraindicated for embolic devices (coils and/
or plug).
PRECAUTIONS
• The MVP Device consists of a nickel-titanium alloy that is generally considered safe.
However, in-vitro testing demonstrated that nickel is released from the device for 60
days minimum. Patients who are allergic to nickel may have an allergic reaction to the
device, especially patients with a history of metal allergies. Certain allergic reactions
can be serious; patients should be instructed to notify their physicians immediately if
they suspect they are experiencing an allergic reaction such as di culty breathing or
in ammation of the face or throat. Some patients may develop an allergy to nickel if
the device is implanted.
• Physicians should exercise clinical judgment in situations that involve use of
anticoagulants or antiplatelet drugs before, during and/or after use of the device.
• Please note care in speci c populations: pregnancy – care should be taken to minimize
Partial Cover
radiation exposure to the mother and fetus, and nursing mothers – there has been no
quantitative assessment of the presence of leachables in breast milk.
Distal Marker
• Verify MVP System compatibility when using other ancillary devices in intravascular
procedures. Physician must be familiar with percutaneous, intravascular techniques
and possible complications associated with the procedure.
• The MVP System should be hydrated prior to use.
• Exercise care in handling the MVP System to reduce the chance of accidental damage.
• There is a potential for higher push forces when used with slotted nitinol composite
microcatheters.
MVP Device
• Verify that the diameter of any accessory device that is used is compatible with the
MVP System prior to use.
• Potential adverse events that may occur during or after a procedure placing this device
include, but are not limited to:
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A. Diameter
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Target Vessel Diameter
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1.5 – 3.0mm
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3.0 – 5.0mm
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MATERIALS REQUIRED FOR USE WITH THE MVP
SYSTEM
1. Delivery of the MVP System requires the use of a Microcatheter (see Table 2 for
recommended size).
2. Accessories required:
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MRI INFORMATION
MR Conditional
The MVP® Micro Vascular Plug was determined to be MR conditional.
Non-clinical testing demonstrated that the MVP® Micro Vascular Plug Device is MR
Conditional. A patient with this device can be scanned safely, immediately after placement
under the following conditions:
• Static magnetic eld of 3-Tesla or less
• Maximum spatial gradient magnetic eld of 9,000-Gauss/cm or less
• Maximum MR system reported, whole body averaged speci c absorption rate (SAR) of
4-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
• First Level Controlled Operating Mode for the MR system
MRI RELATED HEATING
In non-clinical testing, the MVP® Micro Vascular Plug Device produced the following
temperature rise during MRI performed for 15-min of scanning (i.e., per pulse sequence) in
the 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare,
Milwaukee, WI) MR system:
Highest temperature change +1.7º C
Therefore, the MRI-related heating experiments for the MVP® Micro Vascular Plug Device at
3- Tesla using a transmit/receive RF body coil at an MR system reported whole body averaged
Air embolus
Allergic reaction/toxic e ects
Bleeding
Death
Device migration
Fever
Foreign material embolic event
Hemolysis
Infection
Occlusion of unintended vessel
Peripheral embolism
Recanalization
Residual ow
Stroke/TIA
Surgical intervention
Vascular access site complication
Vessel trauma/perforation
Heparinized Saline Solution
Rotating Hemostatic Valve (RHV)
3-Way Stopcock
Saline Bag Cu
Access Sheath
Guide Catheter compatible with a Microcatheter recommended in Table 2
Guide Wire compatible with the Guide Catheter and microcatheter
Infusion Stand
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 speci c conditions was equal to or less than +1.7º C.
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 MVP® Micro Vascular Plug Device . Therefore,
optimization of MR imaging parameters to compensate for the presence of this device may
be necessary. The maximum artifact size (i.e., as seen on the gradient echo pulse sequence)
extends approximately 5-mm relative to the size and shape of the MVP® Micro Vascular Plug
Device.
Pulse Sequence T1-SE T1-SE
Signal Void Size 70-mm 2 51-mm 2
Plane Orientation Parallel Perpendicular
PREPARATION FOR USE
1. In order to achieve optimal performance of the MVP System and to reduce the risk
of thromboembolic complication, a continuous saline ush should be maintained
between a) access sheath and guide catheter, b) Microcatheter and guide catheter,
and c) Microcatheter and guidewire and MVP System.
2. Place the appropriate guide catheter following recommended procedure. Connect
a rotating hemostatic valve (RHV) to the hub of the guide catheter. Attach a 3-way
stopcock to the side arm of the RHV. Connect a heparinized saline line for continuous
ush.
3. Check all ttings so air is not introduced into guide catheter or Microcatheter during
continuous ush.
DIRECTIONS FOR USE
1. Access the targeted vessel and perform an angiogram using standard technique to
measure the vessel diameter at the desired occlusion site. Ensure the targeted vessel
meets the recommended diameter (see Table 1).
2. Ensure that the occlusion site is long enough to accommodate the implanted MVP
Device without obstructing unintended vessels.
3. Select a Microcatheter (see Table 2 for recommended size) and prepare according to
the manufacturer's instructions for use.
Note: the delivery Microcatheter length must be less than or equal to 150cm.
4. Insert the guidewire and advance the Microcatheter over the guidewire until the distal
tip is near the leading edge of the occlusion site.
5. Remove the guidewire from the Microcatheter.
6. Remove the MVP System from the dispenser tube by gently removing the yellow
Introducer Sheath from the two outer clips and pull the MVP System out of the Clear
Housing Tube. Gently grasp the Introducer Sheath proximal to the MVP Device, slowly
remove the MVP Device, delivery wire and introducer sheath simultaneously from the
dispenser tube. See Figure 2.
Clear housing tube
MVP device
Yellow Introducer Sheath
Dispenser tube
Figure 2. Packaged MVP System
7. Inspect the MVP System thoroughly for damage. If damage exists, replace with a
new MVP System.
8. Flush the MVP System by gently immersing a few centimeters of the introducer sheath
and the MVP Device in heparinized saline.
9. Draw the MVP Device into the Introducer Sheath by pulling the delivery wire until the
distal tip of the MVP Device is just covered by the Introducer Sheath.
Note: If the MVP Device is pulled too far into the introducer sheath it may not ush
correctly; two holes in the introducer sheath located 3 cm and 6cm proximal to the tip
facilitate air purging and ushing.
10. Insert the MVP System, by inserting the distal end of the Introducer Sheath through
the RHV and into the hub of the Microcatheter until the sheath is rmly seated.
Tighten the RHV to prevent back ow of blood, but not so tight as to damage the MVP
System during its introduction into the Microcatheter.
11. Visually verify the ushing solution is infusing normally. Saline drip should be seen
exiting the proximal end of the introducer sheath.
12. Loosen the RHV enough to advance the MVP Device and delivery wire as a system,
but not enough to allow back ow of blood. Remove the Introducer Sheath over the
delivery wire's proximal end.
13. Advance the delivery wire and MVP Device until the distal platinum marker of the MVP
Device is aligned with the Microcatheter distal marker band.
14. Con rm that the marker bands are positioned optimally, and deploy the MVP Device
by maintaining forward pressure on the delivery wire and unsheath the MVP Device by
pulling the Microcatheter back slowly.
15. If the device position is unsatisfactory:
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Stabilize the delivery wire and advance the Microcatheter distally until the
MVP Device is recaptured within the catheter.
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Reposition and deploy the device, or remove the device from the patient.
GRE GRE
187-mm 2 115 mm 2
Parallel Perpendicular
Deliver Wire
(Inside Introducer
Sheath)
Torquer