Medtronic Endeavor Resolute Produktbeschreibung Seite 8

Table 3 - Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
Inner Diameter (mm) vs. Inflation Pressure (kPa and atm)
Pressure Nominal and
Rated Burst
Pressure
kPa atm
608 6
709 7
811 8
912 9 Nominal*
1013 10
1115 11
1216 12
1317 13
1419 14
RBP** for
1520 15
4.0 mm only
1621 16 RBP**
1723 17
1824 18
* Nominal Deployment Pressure 912 kPa (9 atm)
** Rated Burst Pressure. 1621 kPa (16 atm) for stent diameters up to 3.5 mm, 1520 kPa (15 atm) for 4.0 mm stents.
DO NOT EXCEED.
Note: The nominal in vitro device specification does not take into account lesion resistance. Stent sizing
should be confirmed angiographically.
Note: Balloon pressures should be monitored during inflation. Do not exceed Rated Burst Pressure as
specified on product label as this may result in a ruptured balloon with possible intimal damage and
dissection.
Note: Do not dilate the Endeavor Resolute Stent to a diameter beyond 0.5 mm of its nominal expansion.
2. Open the hemostatic valve to allow removal of
the delivery system.
3. Maintain position of guide catheter and
guidewire to prevent them from being drawn
into the vessel. Very slowly, withdraw the
balloon from the stent maintaining negative
pressure, allowing movement of the
myocardium to gently dislodge the balloon
from the stent.
4. After removal of the delivery system, tighten
the hemostatic valve.
5. Repeat angiography and visually assess the
vessel and the stent for proper expansion.
Note: Should the need arise for placement of a
second stent to adequately cover the lesion
length, placement of the stent most distal in
the artery should be done prior to placement
of the proximal stent, if possible. Safety and
effectiveness of multiple stents has not been
established.
Note: Observation of the patient and angiographic
evaluation of the stent site should be
performed periodically within the first 30
minutes after stent placement. If stent
placement is associated with the onset
of thrombus or suspected thrombus in
the region of the stented segment, an
intracoronary infusion of a thrombolytic agent
is recommended.
Stent Nominal Inner Diameter (mm)
2.25 2.5 2.75 3.0
2.15 2.43 2.62 2.84
2.20 2.48 2.67 2.90
2.24 2.53 2.73 2.96
2.28 2.58 2.80 3.02
2.32 2.62 2.85 3.06
2.36 2.66 2.89 3.10
2.40 2.70 2.93 3.15
2.44 2.73 2.97 3.19
2.48 2.77 3.02 3.24
2.52 2.81 3.07 3.29
2.56 2.85 3.11 3.34
2.60 2.89 3.16 3.38
2.65 3.20 3.44
9.7 STENT / DELIVERY SYSTEM REMOVAL
PRECAUTIONS
If removal of a stent system is required prior to
deployment, ensure that the guide catheter is coaxially
positioned relative to the stent delivery system and
cautiously withdraw the stent delivery system into the
guide catheter. Should unusual resistance be felt at
any time when withdrawing the stent towards the
guide catheter, the Stent Delivery System and the
guide catheter should be removed as a single unit.
This must be done under direct visualization with
fluoroscopy.
When removing the Stent Delivery System and Guide
Catheter as a single unit:
• Do not retract the Stent Delivery System
into the guide catheter. Maintain guidewire
placement across the lesion and carefully
pull back the Stent Delivery System until the
proximal balloon marker of the Stent Delivery
System is aligned with the distal tip of the
guide catheter.
• The system should be pulled back into the
descending aorta toward the arterial sheath.
As the distal end of the guide catheter enters
into the arterial sheath, the catheter will
straighten, allowing safe withdrawal of the
Stent Delivery System into the guide catheter
and the subsequent removal of the Stent
Delivery System and the guide catheter from
the arterial sheath.
Failure to follow these steps and/or applying
excessive force to the Stent Delivery System can
potentially result in loss or damage to the stent
and/or Stent Delivery System components such as
the balloon.
DISCLAIMER OF WARRANTY
3.5 4.0
NOTE: ALTHOUGH THE MEDTRONIC ENDEAVOR
3.25 3.74
RESOLUTE STENT SYSTEM, HEREAFTER
REFERRED TO AS "PRODUCT," HAS BEEN
3.32 3.82
MANUFACTURED UNDER CAREFULLY CONTROLLED
3.40 3.90
CONDITIONS, MEDTRONIC, INC. AND ITS AFFILIATES
(COLLECTIVELY, "MEDTRONIC") HAVE NO CONTROL
3.49 3.96
OVER CONDITIONS UNDER WHICH THIS PRODUCT
3.53 4.01
IS USED. MEDTRONIC, THEREFORE, DISCLAIMS
ALL WARRANTIES, BOTH EXPRESSED AND IMPLIED,
3.57 4.07
WITH RESPECT TO THE PRODUCT, INCLUDING,
3.63 4.11
BUT NOT LIMITED TO, ANY IMPLIED WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A
3.68 4.16
PARTICULAR PURPOSE. MEDTRONIC SHALL NOT
3.73 4.20
BE LIABLE TO ANY PERSON OR ENTITY FOR ANY
MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL
3.78 4.25
OR CONSEQUENTIAL DAMAGES CAUSED BY ANY
USE, DEFECT, FAILURE OR MALFUNCTION OF THE
3.84 4.29
PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES
IS BASED UPON WARRANTY, CONTRACT, TORT OR
3.89 4.34
OTHERWISE. NO PERSON HAS ANY AUTHORITY TO
3.94 4.38
BIND MEDTRONIC TO ANY REPRESENTATION OR
WARRANTY WITH RESPECT TO THE PRODUCT.
The exclusions and limitations set out above are not
intended to and should not be construed so as to
contravene mandatory provisions of applicable law. If
any part or term of this Disclaimer of Warranty is held to
be illegal, unenforceable or in conflict with applicable law
by a court of competent jurisdiction, the validity of the
remaining portions of this Disclaimer of Warranty shall
not be affected.
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