Directions For Use - Bard Peripheral Vascular Distaflo Bypass Grafts Mode D'emploi

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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

ISTAFLO ®

bypass 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 at the distal end.

ISTAFLO ®

bypass grafts have a removable external spiral bead support over

the full length of the graft and can be used where resistance to compression

or kinking is desired.

ISTAFLO ®

bypass grafts with standard and Small Cuff have a one (1) mm

internal diameter reduction over the distal 25 cm of the graft. The D

Mini-Cuff graft has a two (2) mm internal diameter reduction over the distal

25 cm of the graft. This reduction is intended to increase the velocity of flow

as it approaches the cuff area.

Indications for Use

ISTAFLO ®

bypass grafts are intended for bypass or reconstruction of

peripheral arterial blood vessels.

Contraindications

None known.

Warnings

ISTAFLO ®

All D

bypass grafts are supplied sterile and non-pyrogenic

unless the package is opened or damaged. D

are sterilized by ethylene oxide.

Do not use after expiration date printed on the label.

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.

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.

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.

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.

ISTAFLO ®

bypass grafts do not stretch (are non-elastic) in the

longitudinal 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 graft 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.

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. The distal

anastomosis should be made after tunneling or suture disruption

can occur. DO NOT pass the cuff portion (distal end) of the

ISTAFLO ®

bypass graft through a tunneler sheath or the tissue

tunnel, as this could lead to separation of the spiral beading and/or

graft breakage.

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.

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 D

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, create a tunnel that closely approximates the

outer diameter of the graft. A tunnel that is too loose may result in

ISTAFLO ®

delayed healing and may also lead to perigraft seroma formation.

Precautions

Only physicians qualified in vascular surgery techniques should use this

prosthesis. The healthcare provider is responsible for all appropriate

postoperative care instructions to the patient.

The healthcare provider must observe aseptic technique during

implantation and postoperatively.

When removing the external spiral support (beading) of the D

graft, 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. Refer to "Anastomotic

ISTAFLO ®

bypass grafts

Preparation", for further instructions. (Reference Figure 1.)

below the knee and infrapopliteal bypass and are not recommended for

Extra-Anatomic Bypass Applications.

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.

To minimize fluid collection around the graft in Extra-Anatomic bypass

procedures or in peripheral reconstruction procedures, the lymphatics

should be carefully ligated and sealed, especially in the groin area.

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 hematomas or

pseudoaneurysm; infection; skin erosion; aneurysm/dilation; blood leakage;

and hemorrhage.

Equipment Required

Tunneler, double armed sutures, atraumatic clamps, scalpels 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

DO NOT MODIFY THE D

ISTAFLO

The Small Cuff configuration should be used in recipient vessels with

diameters of 4mm or smaller, only, and the Mini-Cuff configuration should be

used in recipient vessels with diameters of 3 mm or smaller only.

(1)

ISTAFLO ®

bypass grafts to temperatures greater

Figure 1

ISTAFLO ®

grafts have been developed for and are especially suitable for