InspireMD MGUARD Prime Instrucciones De Uso página 3

DO NOT REPROCESSE, RESTERILIZE AND/OR REUSE.
InspireMD will not be responsible for any direct, incidental
or consequential damages resulting from reprocessing, re-
sterilization or reuse.
Check expiry date before using the device. If expiry date has
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passed, do not use the device.
Never implant stents of different material close together or
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cross the struts (risk of galvanic potential).
Should any resistance be felt at any time during manipulation,
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insertion or withdrawal of the device, do not force or continue:
stop the procedure immediately and determine the cause of the
resistance before proceeding. If the stent cannot be deployed;
remove the entire stent system and guiding catheter as a unit,
do not attempt to retrieve the stent back through the guiding
catheter, dislodgement of the stent may occur.
If the physician encounters difficulty while trying to cross
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the lesion by direct stenting and determines the lesion
to be non-crossable, this patient should be treated per
predilatation practice.
If the physician encounters difficulty while trying to cross the
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lesion and predilatation is used, do not use the same stent
system because the stent and/or the stent delivery system
may have been damaged during the first attempt to cross the
lesion or during withdrawal.
Appropriate anti-platelet and/or anti-coagulant therapy as
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determined by the physician in accordance with standard
protocols for stent implantation should be administered to
the patient.
When treating multiple lesions, the distal lesion should be
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initially stented, followed by stenting of the proximal lesion.
Stenting in this order eliminates the need to cross the proximal
stent when placing the distal stent and reduces the chances
for stent dislodgment.
Placement of the stent has the potential to compromise side
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branch patency. Side branches with diameter of 2.0 mm and
more should not be covered by the stent.
Do not attempt to cross moderate to heavily calcified target
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lesion or vessel.
5. Precautions
Select proper device size suiting lesion length and reference
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vessel diameter.
Do not attempt to reposition a partially deployed stent as this
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may result in severe vessel damage.
Do not attempt to remove, readjust or touch the stent on its
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delivery system. The stent cannot be removed and placed on
another balloon catheter.
Balloon pressure should not exceed the Rated Burst Pressure
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MGuard Prime
|
PAC-0318-V4
(RBP). Use of a pressure-monitoring device is mandatory to
prevent over-pressurization.
Use only an appropriate balloon inflation medium (a 50:50
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mixture by volume of contrast medium and sterile saline).
Never use air or a gaseous medium to inflate the balloon.
When the catheter is in the body, it should be manipulated
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while under sufficient and/or high quality Fluoroscopy.
While removing the stent protection cap, hold the cap at the
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most distal part. Holding the cap in the proximal part may
cause stent dislodgment.
Use only guide wires with a maximum of 0.014" (0.36 mm)
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diameter.
Exercise care during handling in order to avoid possible damage
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to the stent, sleeve, balloon-catheter and stent-balloon fixation.
Avoid acute bending or kinking of the catheter shaft.
Store in a dark, cool and dry place.
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Inspect the device prior to the procedure, to verify functionality
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and lack of damaged parts. Do not use the device if the outer
or the inner package is damaged or opened.
6. Complications
Possible complications associated with coronary stent implantation
may include, but are not limited to:
Death
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Acute myocardial infarction
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Coronary artery spasm
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Restenosis of the stented artery
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Acute or sub-acute stent thrombosis
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Total occlusion of the coronary artery or bypass graft
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Dissection, perforation or rupture of the coronary artery
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Hypo/hypertension
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Sepsis/infection
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Arrhythmia, including ventricular fibrillation
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Hemorrhage or hematoma
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Arteriovenous fistula
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Embolization
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Stent migration
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Allergic reactions
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Stent Collapse
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Stent breakage or fracture may occur during implantation
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Drug reactions to anti-platelet agents / contrast medium
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Emergent Coronary Artery Bypass Surgery
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Pain at insertion site
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Myocardial Ischemia
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Femoral Pseudoaneurysm
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Stent thrombosis
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Stroke / cerebrovascular accident
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Renal failure
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