Contraindications - Flex Vessel Prep FSC 4-120 Mode D'emploi

III. INDICATIONS FOR USE/INTENDED USE
The FLEX Vessel Prep™ System is indicated for use
with percutaneous transluminal angioplasty (PTA)
catheters to facilitate dilation of stenoses in the
femoral and popliteal arteries and treatment of
obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. The device also is
indicated for treatment of in-stent restenosis of
balloon expandable and self-expanding stents in the
peripheral vasculature
.
IV. CONTRAINDICATIONS
Not for use in the cerebrovascular, coronary, renal,
or mesenteric vasculature.
V. WARNINGS
Never advance the catheter while the Treatment
Element is expanded.
This device is intended for single use only. Do not
resterilize and/or reuse the device, as this can
potentially result
performance and increased risk of inappropriate
resterilization and cross contamination.
The expanded diameter of the Treatment Element
should approximate the reference vessel diameter to
minimize the risk of vessel damage.
When the device is exposed to the vascular system,
it should be manipulated while under high quality
fluoroscopic observation.
Do not advance or withdraw the device from the
lesion site unless the Treatment Element is fully
retracted into the catheter sheath. If resistance is
met during deployment in the lesion, determine the
cause of the resistance before proceeding.
Proceed with caution when using the FLEX Vessel
Prep™ System in or near a recently deployed bare
metal stent or drug-eluting stent. The FLEX Vessel
Prep™ System has not been tested for post-dilatation
of stents or in lesions distal to freshly deployed stents
in clinical studies.
Use the device prior to the "Use Before" (expiration)
date specified on the package.
100073 Revision R
in compromised device
Date of Issue: 2022-06
VI. PRECAUTIONS
A thorough understanding of the principles, clinical
applications and risks associated with PTA is
necessary before using this product.
Any use for procedures other than those indicated in
these instructions is not recommended.
This device is not recommended for use in reference
vessel diameters smaller than 4.0mm.
This device is not recommended for use in highly
calcified lesions.
Do not use if the package is opened or damaged.
Prior to use, the device should be examined to verify
functionality, device integrity and to ensure that its
size and length are suitable for the specific procedure
for which it is to be used.
During and after the procedure, the appropriate anti-
coagulants, anti-platelet agents and vasodilators
should be administered to the patient according to
the institutional practice for peripheral angioplasty
of similar arteries.
Pass the FLEX Vessel Prep™ System through the
recommended introducer sheath indicated on the
product label.
VII. ADVERSE EFFECTS/RESIDUAL RISKS
Possible adverse effects/residual risks include the
following:
o Additional Intervention
o Arterial dissection or perforation
o Arteriovenous fistula
o Bleeding
o Delayed Procedure
o Embolism
o Hemorrhage or hematoma
o Pain and discomfort
o Patient Fever
o Patient Infection
o Patient Septicemia
o Patient Toxicity
o Prolonged Procedure
o Pseudo-Aneurysm
o Retained device components
o Surgery
o Thrombus
o User Dissatisfaction
o Vessel Trauma (includes Arterial spasm)
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