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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
I
ePTFE vascular grafts are constructed of expanded
®
MPRA
polytetrafluoroethylene (ePTFE). I
MPRA
contain carbon impregnated into the inner portions of the graft walls.
Indications for Use
I
ePTFE grafts are indicated for use as vascular prostheses.
®
MPRA
Straight, Tapered, Short Tapered, Stepped, C
E
F
LEX ™
Graft Configurations are intended for use as subcutaneous
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arteriovenous conduits for blood access, bypass, or reconstruction of peripheral
arterial blood vessels. Tapered, short tapered, and stepped configurations may
help minimize the risk of steal syndrome and high cardiac output. C
graft and E
F
LEX ™
graft configurations have a non-removable external spiral
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support (beading) and can be used where resistance to compression or kinking
is desired.
I
F
LEX ™
Graft Configurations are intended for bypass or reconstruction
MPRA
of peripheral arterial blood vessels and have removable spiral support (beading)
over the entire graft. These grafts can be used where resistance to compression
or kink is desired.
Insufficient clinical data are available on which to base any conclusions regarding
the use of Thinwall grafts in blood access or to support the use of I
vascular grafts for applications involving; pulmonary arteries, cerebral arteries,
coronary arteries, brachiocephalic trunk, cardiac vein, pulmonary veins, or the
inferior or superior vena cava.
Contraindications
None known.
Warnings
1.
All I
ePTFE vascular grafts are supplied sterile and non-
®
MPRA
pyrogenic unless the package is open or damaged. I
vascular grafts 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.
Anastomotic or graft disruption has been associated with
Axillofemoral, Femoral Femoral, or Axillobifemoral bypass procedures
if implanted improperly. Refer to Specific Operative Procedures (Extra-
Anatomic Bypass Procedures) for further instructions. Thinwall and
I
F
LEX ™
Thinwall grafts are NOT recommended for these types of
MPRA
bypass procedures.
6.
For Extra-Anatomic procedures, (e.g., Axillofemoral, Femoral
Femoral, or Axillobifemoral Bypass) the patient should be cautioned
that sudden, extreme or strenuous movements should be totally
avoided for a period of at least six to eight weeks to allow for proper
stabilization of the graft. Routine activities such as raising the arms
above the shoulders, reaching out in front, extended reaching,
throwing, pulling, striding or twisting should be avoided.
7.
I
ePTFE grafts do not stretch (are non-elastic) in the longitudinal
®
MPRA
direction. The correct graft length for each procedure must be
determined by considering the patient's body weight, posture, and
the range of motions across the anatomical area of graft implantation.
Failure to cut the grafts to an appropriate length may result in
anastomotic or graft disruption, leading to excessive bleeding, and
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.
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. Do not remove the external spiral support (beading) from any
C
F
LEX ™
graft or E
F
ENTER
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beading may damage the graft wall. If damage occurs, discard the
graft.
11.
Do not cannulate I
F
LEX ™
MPRA
length of the graft or the externally supported portion of C
or E
F
™ grafts. Cannulation at these sites may lead to beading
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LEX
embolization and/or pseudoaneurysm formation.
12. 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.
C
ePTFE vascular grafts also
®
ARBOFLO
F
LEX ™
Graft and
ENTER
ENTER
MPRA
ePTFE
®
MPRA
™ graft. Attempts to remove the
LEX
grafts with external support over the full
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13. 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.
14. 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.
15. Do NOT expose I
500°F (260°C). PTFE decomposes at elevated temperatures producing
highly toxic decomposition products
16. After use, the product may be a potential biohazard. Handle and
dispose of in accordance with acceptable medical practice and
applicable local, state and federal laws and regulations.
17. During tunneling 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.
Precautions
1.
Only physicians qualified in vascular surgery techniques should use this
F
LEX ™
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
and postoperatively.
3.
When removing the external spiral support (beading) of I
grafts, the beading must be removed slowly and at a 90° angle to the graft.
Rapid unwinding and/or removal at less than a 90° angle may result in
graft damage. Do not use surgical blades or sharp, pointed instruments to
remove the beading as this may damage the graft wall. If damage occurs,
that segment of the graft should not be used. (Reference Figure 1.)
®
Note: Do not remove spiral support beading from C
E
F
LEX ™
grafts.
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4.
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.
5.
To minimize fluid collection around the graft in Extra-Anatomic bypass
procedures or in peripheral reconstructive procedures, the lymphatics
should be carefully ligated and sealed, especially in the groin area.
6.
Consider intraoperative and postoperative patient anticoagulation therapy
for each patient as appropriate.
Adverse Reactions
Potential complications which 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 hematoma or
pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal
syndrome; and/or skin erosion.
DIRECTIONS FOR USE
Equipment Required
Tunneler, suture, atraumatic clamp, 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 sterile gloves. Protect the graft against damage from
sharp or heavy instruments.
Tunneling Techniques
Prior to utilizing a sheath tunneler, verify that the graft outer diameter dimensions
fit the sheath internal diameter dimensions.
Use of a sheath tunneler is recommended as it will minimize graft handling,
protect the external reinforcement (Flex Beading) and help maintain graft
integrity.
Always follow the instructions for use for the specific tunneler utilized to place
the graft.
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 lead to perigraft
F
LEX ™
seroma formation. Reference WARNING #8 and #17.
(1)
ePTFE grafts to temperatures greater than
®
MPRA
1
.
ENTER
Figure 1
General Operative Techniques
F
LEX ™
MPRA
LEX ™
F
or
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