English - ev3 Barrel BV-3550 Manual Del Usuario

English

Instructions for Use
Barrel® Vascular Reconstruction
Device
DEVICE DESCRIPTION
The Barrel® Vascular Reconstruction Device (VRD) is a self-expanding design that can be
completely deployed and fully retrieved...
The Barrel® VRD is comprised of nitinol and several platinum marker bands... The proximal
marker band attaches to a wire that pushes the device through a commercially available
0... 0 21" microcatheter to the intended treatment site... The delivery wire detaches from
the Barrel® VRD by electrolytic means after deployment with the Reverse Medical
Detachment System...
The Barrel® VRD is packaged as a single unit with the Barrel® VRD, detachable delivery
wire and introducer sheath... The system is provided sterile, non-pyrogenic, and is
intended for single use only...
The Barrel® VRD is specifically designed for use with the Reverse Medical Detachment
System... The Reverse Medical Detachment System is sold separately...
Figure 1: Reverse Medical Barrel® Vascular
Reconstruction Device
1... Barrel® VRD A... Proximal End Diameter
2... Detachment Zone B... Distal End Diameter
3... Delivery Wire (DW) C... Barrel Diameter
D... Barrel Length
E... Usable Length
Figure 2. Radiopaque Markers
1a... Proximal Marker (1 each)
1b... Proximal Barrel Marker (1 each)
1c... Barrel Center Markers (6 each)
1d... Distal Barrel Marker (1 each)
1e... Distal Markers (3 each)
Table 1. Barrel® Vascular Reconstruction Device Dimensions
Order A... Proximal B... Distal End C... Barrel
Number End Diameter Diameter Diameter
BV-3550 3... 5 mm 3... 0 mm 5... 0 mm
BV-3560 3... 5 mm 3... 0 mm 6... 0 mm
BV-4065 4... 0 mm 3... 5 mm 6... 5 mm
BV-4070 4... 0 mm 3... 5 mm 7... 5 mm
BV-4580 4... 5 mm 4... 0 mm 7... 5 mm
4
Table 2. Recommended Vessel Sizes
EN
Order Number
BV-3550
BV-3560
BV-4065
BV-4070
BV-4580
INDICATIONS FOR USE
The Barrel® Vascular Reconstruction Device is intended for use with occlusive devices in the
treatment of intracranial aneurysms...
CONTRAINDICATIONS
None known...
COMPATIBILITY
Refer to product label for device dimensions... Refer to labeling provided with other medical
technologies to determine compatibility...
WARNINGS
• The Barrel® VRD should only be used by physicians who are familiar with angiographic
and interventional procedures... It is important to read and understand the instructions
for use prior to using this product...
• Use prior to the expiration date printed on the product packaging label...
• The Barrel® VRD 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 Barrel® VRD prior to use for any irregularities or damage and discard if any
inconsistencies are observed...
• The Barrel® VRD 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, resterilized or reused as these processes may damage the components
and surface of the device and compromise performance... In addition, the risk of
infection of a reprocessed device has not been qualified in order to reduce this risk to
an acceptable level... Structural integrity and/or function may be impaired by reuse
or cleaning...
• The Barrel® VRD should be advanced or manipulated under fluoroscopic guidance... Do
not advance or withdraw the device when excessive resistance is met until the cause
of resistance is determined...
• Exercise caution when crossing the detached Barrel® VRD with adjunctive devices...
• Only use the battery operated Reverse Medical Detachment System as the detachment
system power source...
PRECAUTIONS
• The Barrel® VRD 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 difficulty breathing or
inflammation 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 specific populations: pregnancy – care should be taken to minimize
radiation exposure to the mother and fetus, and nursing mothers – there has been no
quantitative assessment of the presence of leachables in breast milk...
• Verify Barrel® VRD compatibility when using other ancillary devices in intravascular
procedures... Physician must be familiar with percutaneous, intravascular techniques
and possible complications associated with the procedure...
• Exercise care in handling the Barrel® VRD to reduce the chance of accidental damage...
• Potential adverse events that may occur during or after a procedure placing this device
include, but not limited to:
◦
Air embolus
◦
Allergic reaction/toxic effects
◦ Bleeding
◦
Death
◦
Device migration
◦
Fever
◦
Foreign material embolic event
◦
Hemolysis
◦ Infection
D... Barrel E... Usable
◦
Occlusion of unintended vessel
Length Length
◦
Peripheral embolism
◦
Recanalization
5... 0 mm 20mm
◦
Residual flow
◦
Stroke/TIA
6... 0 mm 20mm
◦ Surgical intervention
◦
Vascular access site complication
6... 5 mm 20mm
◦
Vessel trauma/perforation
7... 0 mm 21mm
MATERIALS REQUIRED FOR USE WITH THE
BARREL VRD
8... 0 mm 22mm
1... Delivery of the Barrel® VRD requires the use of a 0... 0 21" Microcatheter with 2 marker bands...
2... Reverse Medical Detachment System (ED2-RM) is required to detach the Barrel® VRD
in the desired location... Accessories required:
◦
9-volt alkaline battery
◦
20 or 22 gauge sterile needle
◦
Sterile Cable Set (RMCS-2... 7 5)
MR CONDITIONAL
The Barrel® VRD was determined to be MR conditional...
Recommended Vessel Sizes
Non-clinical testing demonstrated that the Barrel® VRD is MR Conditional... A patient with this
device can be scanned safely, immediately after placement under the following conditions:
2,0-3,0 mm
•
2... 0 -3... 0 mm
•
•
2... 5 -3... 5 mm
•
2... 5 -3... 5 mm
MRI-RELATED HEATING
3... 0 -4... 0 mm
In non-clinical testing, the Barrel® VRD 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... M 5, General Electric Healthcare, Milwaukee, WI) MR system:
Highest temperature change
Therefore, the MRI-related heating experiments for the Barrel® VRD 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... 8 °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 Barrel® VRD... 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 Barrel® VRD...
PREPARATION FOR USE
1...
2...
3...
DIRECTIONS FOR USE
1...
2...
3...
4...
5...
6...
7...
8...
9...
10...
11...
12...
13...
14...
Static magnetic field of 3-Tesla or less
Maximum spatial gradient magnetic field of 720-Gauss/cm or less
Maximum MR system reported, whole body averaged specific 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
+1... 8 °C
Pulse Sequence T1-SE T1-SE
Signal Void Size 187-mm 2 36-mm 2
Plane Orientation Parallel Perpendicular
In order to achieve optimal performance of the Barrel® VRD and to reduce the risk
of thromboembolic complication, a continuous saline flush should be maintained
between a) femoral sheath and guide catheter, b) microcatheter and guide catheter,
and c) microcatheter and delivery wire and Barrel® VRD...
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 line for continuous flush...
Check all fittings so air is not introduced into guide catheter or Microcatheter during
continuous flush...
Access the targeted vessel and perform an angiogram using standard technique to
determine the location and dimensions of the targeted aneurysm and parent vessel...
Ensure the targeted vessel meets the recommended diameter (see Table 2)...
Using angiography, calculate diagonal lines from the vessels distal to the aneurysm,
starting with the continuation of the parent vessel, from the distal shoulder of the
aneurysm back to the opposite wall of the parent vessel... The second diagonal is drawn
from the distal shoulder of the aneurysm at the branch vessel, back to the opposite
wall of the parent vessel... Select which distal vessel will provide the best coverage/
herniation into the aneurysm neck...
Select a size of the device so that there is a minimum of 4 mm of length extending
past each side of the aneurysm neck... An incorrectly sized device may result in
inadequate aneurysm embolization, coil herniation into the parent artery, device
migration, or other vessel damage...
Select a 0... 0 21" Microcatheter with 2 marker bands and prepare according to the
manufacturer's instructions for use...
Note: the delivery Microcatheter length must be less than or equal to 150cm...
Connect a second RHV to the fitting of the microcatheter and connect the tube to
continuous flush...
Flush rate: one drop every 3-5 seconds from the pressurized cuff bag...
Using a suitable guidewire, advance the microcatheter until the tip is positioned at
least 10mm past the distal shoulder of the aneurysm...
Remove the guidewire from the microcatheter...
To remove the Barrel® VRD from the dispenser tube, gently grasp the delivery wire
from the dispenser tube and slowly remove the Barrel® VRD, delivery wire and
introducer sheath simultaneously from the dispenser tube...
Immerse the Barrel® VRD in heparinized saline... Advance the delivery wire to release
the Barrel® VRD from the introducer sheath... Inspect the Barrel® VRD thoroughly for
any irregularities... If irregularities exist, replace with a new Barrel® VRD...
While immersed in heparinized saline, retract the Barrel® VRD back into the introducer
sheath by pulling gently back on the delivery wire... Ensure that the tip of the Barrel®
VRD is just inside the distal tip of the introducer sheath...
Insert the Barrel® VRD, by inserting the distal end of the introducer sheath through the
RHV and into the hub of the Microcatheter until the sheath is firmly seated... Tighten
the RHV to prevent back flow of blood, but not so tight as to damage the Barrel® VRD
during its introduction into the Microcatheter...
Visually verify the flushing solution is infusing normally... Saline drip should be seen
through the proximal end of the introducer sheath...
Loosen the RHV enough to advance the Barrel® VRD and delivery wire as a system, but
not enough to allow back flow of blood into the guide catheter... Advance the delivery
wire a minimum of 60 cm into the catheter... Remove the introducer sheath over the
delivery wire's proximal end...
Advance the delivery wire and Barrel® VRD until the distal platinum marker of the
Barrel® VRD is aligned with the Microcatheter distal marker band... Ensure that prior
GRE GRE
293-mm 2 103 mm 2
Parallel Perpendicular