Potential Adverse Events; Liability And Warranty - CID CRE8 Manual De Instrucciones

MRI Heating
Under the scan conditions defined below, CoCr stent product lines in a single
stent configuration are expected to produce a maximum temperature rise of less
than 2.4 °C in a 1.5 T MRI system and 2.9 °C in a 3 T MRI system.
MR system reported, whole body averaged SAR
Calorimetry measured values, whole body averaged SAR 2.1 W/kg
Highest temperature change
MR Artifact
In non-clinical testing, the image artifact caused by the device extends
approximately 1.0 cm from CoCr stents when imaged with a gradient-echo pulse
sequence in a 3 T MRI system.
8. DRUG REGIME
Studies in clinical literature indicate the need to administer appropriate
anticoagulant, anti-platelet and vasodilation therapy for successful stent
implantation.
Antiplatelet treatment during the period after the procedure should be used per
the guidelines from current ESC or ACC/AHA/SCAI for PCI.
While physicians should adhere to DAPT duration defined into the current ESC
(2017 and subsequent updating) or ACC/AHA/SCAI Guidelines for PCI, the
decision to interrupt or discontinue DAPT is the responsibility of the treating
physician, taking into consideration the individual patient's condition (e.g. non-
deferrable surgery). Guidelines details on indications and modalities for DAPT
interruption are available in the ESC or ACC/AHA/SCAI organizations' websites
(https://www.escardio.org/ https://www.acc.org/ https://www.heart.org/ http://www.
scai.org).
In case unanticipated interruption or discontinuation of DAPT is required any
time after one month following Cre8™ products family implantation, one-year
clinical data of Cre8™ products family indicate low stent thrombosis rates and
no observed increased risk for stent thrombosis.
9. INTERACTIONS WITH DRUGS
Although no specific clinical data are available, certain drugs, such as Tacrolimus,
which act through the same binding protein (FKBP), may interfere with the efficacy
of Sirolimus. Drug interaction studies have not been performed. Sirolimus is
metabolized by CYP3A4. Strong CYP3A4 inhibitors may cause greater exposure
to Sirolimus up to levels associated with systemic effects, especially in the case of
multiple implant. Systemic exposure to Sirolimus if the patient is taking concomitant
systemic immunosuppressive drugs must also be considered.

10. POTENTIAL ADVERSE EVENTS

Possible adverse effects of PTCA include, but are not limited to:
• Access site haematoma or pain
• Acute myocardial infarction
• Allergic reaction (to contrast medium, drugs used during the procedure or the
materials composing the stent)
• Arterial spasm
• Arteriovenous Fistula
• Artery aneurysm or pseudoaneurysm
• Cardiac arrhythmia
• Death
• Dissection, perforation, rupture of the artery
• Distal embolism
• Embolization (air, tissue, device or thrombus)
• Haemorrhage
• Hypo/hypertension
• Infections
• Restenosis of the vessel
• Stent occlusion
• Thrombosis (acute, subacute or late)
• Unstable angina
• Ventricular fibrillation
• Vessel occlusion.
11. DIRECTIONS FOR USE
Auxiliary material (not included in the box)
- Guiding catheter(s) with a 5F diameter (inner diameter 1.47 mm) or larger
- Syringes
- Guidewires 0.014 inches in diameter (0.356 mm) or less
- Inflation device
- Introducer
Model
Each Cre8™ device is identified by a model code and a lot number; available
product codes are listed in Table 1. The code is composed of the letters IC,
followed by two letters identifying the type of device, two or three digits indicating
the nominal diameter of expansion of the stent and a further two digits indicating
the length of the stent.
The batch number allows traceability of all information regarding device
manufacture and system control in the Quality Assurance archives of the
Manufacturer.
To facilitate traceability of the device at the user end, the product code is printed
on the adhesive labels included on each box; these labels can be attached to
the implant patient's medical chart.
Stent + delivery catheter preparation
During preparation of the system, take special care not to let to any liquid
come into contact with the stent. However, if it is absolutely necessary to
flush the stent with sterile/isotonic saline solution, the contact time should
be limited (maximum one minute).
The stent should be implanted in the target lesion using its delivery catheter.
After having examined the package for any damage, remove the CRE8™ device
and bring it into a sterile area.
a) Check that the delivery catheter does not present kinks, bends or other
damage.
1.5 T 3 T b) Carefully slide the protective cover off the stent by grasping the cover at the
2.9 W/kg 2.9 W/kg distal end do not touch the part of the cover over or proximal to the stent.
2.7 W/kg Check that the stent is intact and well centered on the balloon.
2.4 °C 2.9 °C Damage to the CRE8™ device may impair its performance. If the stent
is out of place or damaged, do not use it.
c) Flush guidewire lumen with heparin/saline mixture. Caution: do not place
the stent into contact with liquids while flushing the guidewire lumen.
d) Prepare the inflation device according to the manufacturer's instructions with
dilute contrast medium.
e) Purge any air from the balloon the stent is mounted on as follows:
1) Fill the inflation device/syringe with 4 ml of contrast medium diluted (50%
contrast medium and 50% sterile saline solution);
2) After connecting the inflation device/syringe to the delivery catheter Luer
connector, point the distal tip of the catheter (balloon) downwards vertically;
3) Apply negative pressure and aspirate for at least 30 seconds. Allow the
pressure to rise gradually back to neutral as the system fills with contrast
medium.
4) Disconnect the inflation device/ syringe from the luer connection and remove
all air.
5) Without introducing air, repeat steps 2 and 3 and aspirate for 10-15 seconds
until air bubbles no longer appear.
Stent insertion
The guiding catheters with a 5F diameter (inner diameter 1.47 mm) or larger
are compatible for use with the CRE8™ device.
Coronary guidewires 0.014 inches in diameter (0.356 mm) or less are
compatible for use with the CRE8™ device. The choice of guidewire
stiffness and tip configuration will depend on the physician's clinical
experience.
a) Keep the delivery catheter the stent is crimped on at ambient pressure during
insertion (neutral pressure).
b) Flush the exposed portion of the guidewire with a heparin/saline mixture to
remove traces of blood and contrast medium.
c) Ensure that the haemostasis valve is completely open before introducing the
system.
d) Thread the distal tip of the catheter over the proximal end of the guidewire
until the guidewire exits the catheter body at the guidewire exit port.
e) Slowly advance the dilatation catheter until the appropriate depth marker aligns
with the haemostatic valve hub. This indicates that the balloon is exiting the
guiding catheter.
f) Under fluoroscopy, slowly advance the system over the guidewire to allow the
blood the retrograde filling of the guiding catheter; keep advancing the system
until the stent reaches the treatment site.
g) When advancing the delivery system into the target vessel, make sure that the
stent and the delivery balloon move as a single unit. This should be done by
observing, under fluoroscopy, the position of the balloon radiopaque markers
in relation to the stent radiopaque markers.
If resistance is encountered at any time, do not force the system: withdraw
the CRE8™ device and the guiding catheter as a single unit. Applying
excessive force and/or incorrectly handling the system may lead to stent
deployment or damage to the delivery catheter.
Stent implantation and expansion
a) Position the stent and, with the help of the balloon's radiopaque markers,
make sure it is correctly positioned in relation to the lesion to be treated and
completely covering it.
b) Expand the stent by slowly inflating the balloon to the nominal diameter. Table
2 lists the diameters of the balloon as inflation pressure varies (column I), for
the seven nominal diameter groups: 2.25 mm (column II), 2.5 mm (column
III), 2.75 mm (column IV), 3.0 mm (column V), 3.5 mm (column VI), 4.0 mm
(column VII) and 4.5 mm (column VIII). Values on dark background refer to
pressures above the Rated Burst Pressure*. The stent expands at a minimum
balloon inflation pressure of about 5 atm.
c) Stent elastic recoil is between 2 and 7%* depending on stent model and
expansion diameter.
* NOTE: These values are obtained from the results of in-vitro testing
d) Deflate the balloon and check angiographically that the stent has fully
expanded. If necessary, re-inflate the balloon for optimal implantation.
e) Before withdrawing the delivery catheter, maintain negative pressure for a
minimum of 30 seconds, as per routine PTCA procedure. Ensure the balloon
is fully deflated before and remove the catheter. A device with larger and longer
balloon requires a longer deflation time.
f) If post-dilatation of the stent is required, a PTCA balloon can be used. Use
extreme care:
not to expand the 2.25 mm nominal diameter stent over 2.55 mm.
not to expand the 2.50 – 2.75 mm nominal diameter stents over 3.05 mm.
not to expand the 3.00 – 3.50 mm nominal diameter stents over 3.85 mm.
not to expand the 4.00 – 4.50 mm nominal diameter stent over 5.05 mm.
Optimal expansion requires the stent to be in full contact with the arterial
wall, so that the stent diameter equals the diameter of the reference vessel.
ENSURE THAT THE STENT IS FULLY EXPANDED.

12. LIABILITY AND WARRANTY

The Manufacturer guarantees that this device has been designed, manufactured
and packaged with the greatest care, using the most appropriate procedures the
current state of technology allows. The safety standards integrated into the design
and manufacture of the product guarantee its safe use under the aforestated
conditions and for its intended purposes in observation of the precautions listed
above. These safety standards are meant to reduce as far as possible, but not
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