phenox p48 MW Mode D'emploi page 8

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The p48 MW (HPC) is a delicate implant and requires careful handling. Never push the
microcatheter onto the p48 MW (HPC) against resistance. Never twist the delivery system.
If necessary, remove the p48 MW (HPC) along with the microcatheter.
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Forceful pulling or pushing or twisting on the delivery system may inadvertently detach
the p48 MW (HPC) from the delivery system. In such a case, recovery with a foreign body
retrieval device (e.g. Microsnare Kit, ev3/Covidien/Medtronic) is recommended.
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Extreme stress to the delivery system tip could lead to separation of some of its parts. In
such cases, recovery with a foreign body retrieval device (e.g. Microsnare Kit, ev3/Covidien/
Medtronic) is recommended.
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If there is the risk that the patient is unresponsive or not fully responding to dual antiplatelet
therapy, the time between implant deployment and detachment is supposed to be as short
as possible to avoid any insufficient deployment of proximal implant end by bonding of
braiding wires caused by blood ingredients (e.g. fibrin).
Any additional treatment (e.g. coiling of the aneurysm while the associated microcatheter
is "jailed" by the deployed p48 MW (HPC)) is supposed to be done after p48 MW (HPC)
detachment.
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Do not detach the implant in case of poor wall apposition or if the implant is in a stretched
condition. Improve expansion by re-deploying or removing/replacing the device.
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If not all the implant's braiding wires emerge from the soft pad at the distal end of the
transport tube, careful movement of the delivery system helps to loosen them.
•
Time between start of implant deployment and complete deployment resulting in a
detachment must be as short as possible, in order to prevent any bonding effects by blood
ingredients and ultimately poor proximal implant deployment.
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Insufficient deployment of the proximal implant end can be improved by manipulation with
the delivery system, the microcatheter, or means of a subsequent balloon dilatation. If the
proximal end of the p48 MW (HPC) does not open, recovery with a foreign body retrieval
device (e.g. Microsnare Kit, ev3/Covidien/Medtronic) is recommended.
•
If vasospasm is suspected in the affected vascular region, all necessary measures,
e.g. medication, should be used to aid regression prior to implantation.
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For delivery wire withdrawal use a separate torque device locked to the delivery wire.
A suitable torquer is compatible with microguidewires that are 0.014 to 0.016 inches in
diameter.
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If the torquer cannot be removed from the transport tube (by unscrewing and pulling it in the
proximal direction), unscrew the torquer device completely. A higher resistance may be felt
prior to complete separation of torquer handle and cap. Remove the torquer handle while
the torquer cap and inlay stay in place. Then continue using the separate torque device for
the process of delivery wire withdrawal.
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If the implant cannot be detached or is not supposed to be detached after torquer release
after the delivery wire was moved proximally and the p48 MW (HPC) implant needs to be
removed, gently place the delivery wire again distally to enable that then the microcatheter
can recover implant and delivery wire tip.
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If the distal marker of the transport tube displaces by the movement of the delivery wire,
remove the entire p48 MW (HPC) system considering the above mentioned precautions.
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Patients with known hypersensitivity to nickel-titanium materials may suffer an allergic
reaction to the implant.
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Medication: Prior and following implantation of a p48 MW (HPC) antiplatelet medication
is necessary as described in the chapter "Recommended procedure". Be mindful of
possible interactions with other medications (e.g. with proton pump inhibitors, Ibuprofen,
Metamizole).
In vitro test results and initial clinical experience demonstrate that the version p48 MW HPC
can provide a reduced surface thrombogenecity. In justified exceptional cases the reduced
thrombogenecity can allow the implantation under single antiplatelet medication, only if there
no reasonable alternative therapy given. Here particular attention is to be paid to at leat
three days medication prior to treatment. The achieved platelet inhibition is more intensive
by using P2Y12 inhibitors (Prasugrel, Ticagrelor) than by using ASA.
For safety reasons, the efficacy of the antiplatelet medication is always to be verified by
means of appropriate tests (e.g. Multiplate, VerifyNow, PFA).
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Certification: The implant may only be used by specialized and appropriately trained
physicians. Completion of a product training course run by phenox GmbH is a prerequisite
for the use of the p48 MW (HPC). At least three (3) interventions using the p48 MW (HPC)
must be supervised by a physician or other qualified person delegated by phenox GmbH,
and their course and outcome must be documented.
General information
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Keep away from heat. Store in a cool, dry place.
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Use is only permissible prior to the expiration date, as sterility is not guaranteed otherwise.
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Do not use if packaging is damaged, as sterility cannot be assumed otherwise.
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The device must be checked for damage before use. Do not use deformed or damaged
devices, as function cannot be assumed otherwise.
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The product is intended for single use only. The implant must not be withdrawn into its peel-
away sheath, resterilized or reprocessed for use in other patients since it cannot be cleaned
reliably.
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The delivery system and, where necessary, packaging components must be disposed of
appropriately in marked containers.
8 B842B p48 MW IFU / 2018-07-16
Complications
The following complications, amongst others, may arise during or after implant of the
p48 MW (HPC):
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Air embolism, embolism in distal vessels, vessel occlusion, thrombosis and cerebral
ischemia
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Perforation, rupture, dissection and other arterial lesions
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Occlusion of side branch/perforator
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(Transient) stenosis of target vessel
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Vasospasm, occurrence of a pseudoaneurysm, intracranial hemorrhage
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Reccurrence of aneurysm, retreatment of aneurysm
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Allergic reaction, infection
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Space-occupying infarction, neurological deficit including the consequences of a stroke
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Persistent vegetative state, death
Magnetic resonance imaging
Non-clinical tests have shown that the p48 MW (HPC) is suitable for MRI at a magnetic flux
density of 3T. Under clinical conditions, 1.5T has proven to be unproblematic for the implant.
Symbols and their meaning
Y
Caution
i
Consult instructions for use
D
Do not reuse
B
Do not resterilize
g
Batch code
yQ
Sterilized using ethylene oxide
L
Do not use if package is damaged
Non-pyrogenic
H
Use-by date
h
Catalog number
Content
pw
Keep dry. Keep away from sunlight.
This product was brought onto the market in accordance with
Directive 93/42/EEC concerning medical devices.
M
Manufacturer
MAT
Material: NiTi (Nickel titanium alloy)
NiTi
Limitation of liability
phenox GmbH shall not be liable for damage caused by use other than that intended of the
product.
phenox and p48 are registered trademarks of phenox GmbH in the Federal Republic of
Germany and other states.