Stryker Neuroform EZ Instrucciones De Uso página 6

Deploy the distal end of the stent as precisely as possible with respect to the aneurysm neck to assure
at least 4 mm of each end of the stent lies along the parent vessel. Ensure accurate measurement of the
aneurysm neck so that, when the stent is properly sized per Table 1, the proximal end of the stent will
deploy at the correct location, even if it is difficult to see it because of curves in the vessel.
Q: Which stent size should I choose if I intend to place the stent in a vessel that has a different diameter
between the proximal and distal ends of the stent? Example: Vessel increases from 2 mm PCA (posterior
communicating artery) to a 3.4 mm basilar.
A: Choose the stent sized for the larger vessel. In this example, choose the 3.5 mm stent. This stent can be
deployed safely in the smaller PCA and will be well anchored in the basilar artery.
Q: Is there any problem with deploying the stent across a branch vessel? Can the stent be safely
deployed across the anterior choroidal artery? What about lenticulostriate arteries or perforators
arising from the basilar?
A: No adverse events resulting from branch vessel occlusion or emboli to "jailed" vessels have been
observed in the limited clinical study conducted on this stent (26 patients followed through 6 months).
Stents have been placed extending from the M1 (middle cerebral artery, first segment) to the ICA
(internal carotid artery) without problems.
Q: A loop, or several loops, of a coil (especially a small diameter coil such as 2 mm) are protruding through
the interstices of the stent, and I am unable to reposition it. What should I do?
A: If the risk of leaving part of the coil in the parent vessel is unacceptable, place a second stent inside the
first stent to pin the herniated coil portion against the wall of the vessel. Three-dimensional angiography
using an orthogonal view (i.e., "down the barrel") may be helpful to assess whether or not a coil loop is
inside the lumen of the stent, in the parent vessel, or between the wall of the vessel and the stent. Strict
attention to heparinization and antiplatelet medication is important.
Q: I have accidentally started to deploy the stent, but it is not in the location that I wanted. What
should I do?
A: The safest course of action generally is not to try repositioning the stent, but to continue to deploy the
stent where it is, and then deploy a second stent at the desired location. Safely deploying a stent, even
in an undesired location will minimize vascular injury. Animal studies have demonstrated that the stent
endothelializes in less than 30 days.
Q: I misjudged the positioning of the stent and have deployed it with one end adjacent to the aneurysm
rather than in the normal part of the parent vessel. What should I do?
A: Remove the Neuroform EZ™ Stent System from the microcatheter while maintaining the position of the
microcatheter. Insert and deploy a second stent starting from inside from the first stent to the normal
portion of the parent vessel (telescoping stents). The second stent should be of the same diameter or
larger than the first.
warranTY
Stryker Neurovascular warrants that reasonable care has been used in the design and manufacture of this
instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein,
whether express or implied by operation of law or otherwise, including, but not limited to, any implied
warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization
of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and
other matters beyond Stryker Neurovascular's control directly affect the instrument and the results obtained
from its use. Stryker Neurovascular's obligation under this warranty is limited to the repair or replacement of
this instrument and Stryker Neurovascular shall not be liable for any incidental or consequential loss, damage
or expense directly or indirectly arising from the use of this instrument. Stryker Neurovascular neither
assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility
in connection with this instrument. Stryker neurovascular assumes no liability with respect to instruments
reused, reprocessed or resterilized and makes no warranties, express or implied, including but not limited
to merchantability or fitness for a particular purpose, with respect to such instruments.
Black (K) ∆E ≤5.0
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