Directions For Use - Bard Peripheral Vascular VENAFLO II ePTFE Mode D'emploi

INSTRUCTIONS FOR USE
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
Device Description, Indications, Contraindications, Warnings,
Precautions and Adverse Reactions
Device Description
V
®
ENAFLO II ePTFE Vascular Grafts are constructed of expanded
polytetrafluoroethylene (ePTFE) with carbon impregnated into the inner portions
of the graft wall. This graft is also modified with a proprietary cuff with trim lines
at the venous end.
Stepped configurations may help minimize the risk of arterial steal syndrome and
high cardiac output. C F ™ graft configurations have an external spiral
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bead support on the center of the graft and can be used where resistance to
compression or kinking is desired.
Indications for Use
V ® II Vascular Grafts in Straight, Stepped, C
ENAFLO
C F ™ configurations are indicated for use as subcutaneous
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arteriovenous conduits for blood access only.
Contraindications
None known.
Warnings
1. All V
®
ENAFLO II ePTFE vascular grafts are supplied sterile and non-
pyrogenic unless the package is opened or damaged. V
are sterilized by ethylene oxide. Each graft is intended for single patient
use only. DO NOT RESTERILIZE.
2. This device has been designed for single use only. Reusing this
medical device bears the risk of cross-patient contamination as
medical devices – particularly those with long and small lumina, joints,
and/or crevices between components – are difficult or impossible
to clean once body fluids or tissues with potential pyrogenic or
microbial contamination have had contact with the medical device for
an indeterminable period of time. The residue of biological material
can promote the contamination of the device with pyrogens or
microorganisms which may lead to infectious complications.
3. Do not resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or microbial contamination which may lead to infectious complications.
Cleaning, reprocessing and/or resterilization of the present medical
device increases the probability that the device will malfunction due to
potential adverse effects on components that are influenced by thermal
and/or mechanical changes.
4. Do not use after expiration date printed on the label.
5. Do NOT cannulate the externally supported portion of any V
ePTFE vascular graft due to the risk of beading embolization and/or
pseudoaneurysm.
6. DO NOT REMOVE THE EXTERNAL SPIRAL BEAD SUPPORT FROM ANY
C F ™ CONFIGURED GRAFT. Attempts to remove the beading
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may damage the graft. If damage occurs, discard the graft.
7. V ®
ENAFLO II grafts do not stretch (are non-elastic) in the longitudinal
direction. Failure to cut the graft to an appropriate length may result in
anastomotic or graft disruption, leading to excessive bleeding, loss of
limb or limb function, and/or death.
8. Aggressive and/or excessive graft manipulation when tunneling, or
placement within a too tight or too small tunnel, may lead to separation
of the spiral beading and/or graft breakage. DO NOT pass the cuff
portion (venous end) of the V
or the tissue tunnel, as this could lead to separation of the spiral beading
and/or graft breakage.
9. When embolectomy or balloon angioplasty catheters are used within
the lumen of the graft, the inflated balloon size must match the inner
diameter of the graft. Over-inflation of the balloon or use of an
inappropriately sized balloon may dilate or damage the graft.
10. Avoid repeated or excessive clamping at the same location on the graft.
If clamping is necessary, use only atraumatic or appropriate vascular
smooth jawed clamps to avoid damage to the graft wall. Do not clamp
the cuffed portion of the graft.
11. Exposure to solutions (e.g., alcohol, oil, aqueous solutions, etc.)
may result in loss of the graft's hydrophobic properties. Loss of the
hydrophobic barrier may result in graft wall leakage. Preclotting of this
graft is unnecessary. 1
12. Avoid excessive graft manipulation after exposure to blood or body
fluids. Do not forcibly inject any solution through the lumen of the graft,
or fill the graft with fluid prior to pulling it through the tunnel as loss of
the graft's hydrophobic properties may occur. Loss of the hydrophobic
barrier may result in graft wall leakage.
13. Do NOT expose V ®
ENAFLO II grafts to temperatures greater than 500°F
(260°C). PTFE decomposes at elevated temperatures, producing highly
toxic decomposition products.
14. After use, this product may be a potential biohazard. Handle and
dispose of in accordance with accepted medical practice and applicable
laws and regulations.
15. During tunneling, be sure to create a tunnel that closely approximates
the outer diameter of the graft. A tunnel that is too loose may result in
delayed healing and may also lead to perigraft seroma formation.
16. Care should be taken when cannulating the graft for dialysis access;
avoid the cuff area and the C
rotate cannulation sites, and use proper compression to achieve
hemostasis during post-cannulation care.
F ™, and Stepped
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ENAFLO
ENAFLO
®
ENAFLO II graft through a tunneler sheath
2
F ™ external support, properly
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Precautions
1. Only physicians qualified in vascular surgery techniques should implant this
prosthesis. The healthcare provider is responsible for all appropriate
postoperative care instructions to the patient.
2. The healthcare provider must observe aseptic technique during implantation,
postoperatively, and during cannulation.
3. When suturing, avoid excessive tension on the suture line, inappropriate
suture spacing and bites, and gaps between the graft and host vessel. Failure
to follow correct suturing techniques may result in suture-hole elongation,
suture pull-out, anastomotic bleeding and/or disruption. Refer to "Suturing" for
further instructions.
4. Do not cannulate the cuffed portion of the graft. For further instructions, refer
to the "Blood Access" section.
5. Consider intraoperative and postoperative anticoagulation therapy for each
patient as appropriate.
Adverse Reactions
Potential complications that may occur with any surgical procedure involving
a vascular prosthesis include, but are not limited to: Disruption or tearing
of the suture line, graft, and/or host vessel; suture-hole bleeding; graft
redundancy; thrombosis; embolic events; occlusion or stenosis; ultrafiltration;
seroma formation; swelling of the implanted limb; formation of hematomas or
pseudoaneurysm; infection; arterial steal syndrome; aneurysm/dilation; blood
leakage; hemorrhage; and/or skin erosion.

DIRECTIONS FOR USE

Equipment Required
®
II grafts
Tunneler, double armed suture, atraumatic clamp, scalpel and/or scissors.
Opening the Package
Hold the outer tray in one hand. Peel back the lid. Remove the inner tray.
Peel back the inner tray lid slowly and carefully remove the graft using sterile
atraumatic instruments or gloves. Protect the graft against damage from sharp or
heavy instruments.
Sizing
Use the following guidelines when sizing the cuffed end of all V
ePTFE vascular grafts for the venous anastomosis.
Size of Vein
(External Diameter)
>8mm
®
II
6-8mm
3-5mm
Trimming Recommendations
Hold the graft with the cuff in an open configuration, as shown in Figure 1.
Using curved scissors, start trimming the cuff on the dashed line located nearest
the heel. (See Figure 2.) Continue trimming on the dashed lines following the
curvature suggested.
Note: Do not fold the graft cuff in half when trimming. Do not trim material
from the heel.
Figure 1
Tunneling Recommendations
Create a tunnel that closely approximates the outer diameter of the graft. Always
follow the Instructions for Use for the specific tunneler utilized to place the
V
®
ENAFLO II ePTFE vascular graft.
WARNING: A tunnel that is too loose may result in delayed healing and may also
lead to perigraft seroma formation. See Warning #15.
Note: Prior to utilizing a sheath tunneler, verify that the V
O.D. dimensions fit the sheath I.D. dimensions.
V
®
ENAFLO II ePTFE Vascular Grafts in Straight Anatomical Configurations:
After selecting the appropriate tunneler, introduce the tunneler through the arterial
site. After creating the tunnel, feed the graft from the venous end to the arterial
end. (See Figure 3.) Ensure the cuffed end does not pass through the tunnel.
Only the arterial end of the V
length.
(1)
General Operative Techniques
Cuff Sizing
(See Figure 1)
Do not trim
Trim on the line labeled 6-8
Trim on the line labeled 3-5
Figure 2
®
ENAFLO II ePTFE vascular graft should be sized for
Figure 3
®
ENAFLO II
®
ENAFLO II graft