Symbols And Their Meanings; Limitation Of Liability; General Information - phenox pCANVAS Mode D'emploi

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Do not use the implant in target vessels whose diameter is not within the range of application. If the

parent vessel is too small, this may lead to incomplete deployment of the stent shaft. If this is the case,

access to the aneurysm may not be possible. In addition, a stent which has not deployed fully may

cause early in-stent thrombosis. If the diameter of the parent vessel is larger than the shaft diameter,

the pCANVAS cannot be reliably anchored in the vessel. The crown of the pCANVAS is then

unstable and may be displaced through the blood ﬂ ow or in addition possibly during coil insertion.

Depending on the size of the parent vessel and the selected implant size, additional coiling is

to be used for stabilization. The use of pCANVAS without additional coils is permissible only for

parent vessel diameters between 2.5 and 3.0 mm, with the use of implants with the longer shaft

(pCAN-4-25-xx) and for aneurysms with a neck diameter of 8 mm or less (see Tab. 1).

Vessel Ø

2.5 – 3.0 mm

pCAN-4-20-5

with coils

pCAN-4-20-6

with coils

pCAN-4-20-8

with coils

pCAN-4-20-10

with coils

pCAN-4-25-5

with or without coils

pCAN-4-25-6

with or without coils

pCAN-4-25-8

with or without coils

pCAN-4-25-10

with coils

Tab. 1: Overview of operating conditions of pCANVAS with and without coils

Precautions

•

After insertion of the the pCANVAS into the introducer sheath do not push it out to inspect it;

subsequent retraction would place unnecessary stress on the implant.

•

The pCANVAS may be released up to three (3) times in the aneurysm or target vessel.

•

Thorough rinsing of the introducer sheath is essential in order to remove any trapped air

bubbles.

•

All manipulations inside the patient must be carried out under ﬂ uoroscopic control.

•

If the implant is deployed in such a way that its tip (which emerges from the microcatheter)

points towards the aneurysm, the aneurysm may be perforated.

•

Retrieval: Do not pull the deployed implant back through the aneurysm or parent vessel. To

ensure a controlled and atraumatic retrieval, push the microcatheter over the pCANVAS.

Please ensure that the microcatheter is advanced and the pCANVAS is withdrawn to the

same degree and that these movements are coordinated in such a way that no change in

the location of the pCANVAS results.

•

Carry out this procedure very slowly. An uncontrolled or abrupt retrieval of the pCANVAS

may lead to perforation of the aneurysm and/or dissection of the parent vessel.

•

If vasospasm is suspected in the aﬀ ected vascular region, all necessary measures, e.g.

medication, should be taken to reduce the vasospasm prior to implantation.

•

Patients with known hypersensitivity to nickel-titanium materials may suﬀ er an allergic

reaction to the implant.

•

The pCANVAS is a very delicate implant and requires careful handling. Never push the

microcatheter onto the pCANVAS against resistance. Never twist the insertion system. If

necessary, please remove the pCANVAS along with the microcatheter.

•

Forceful pulling or pushing on the insertion wire, and also twisting the insertion wire, may

inadvertently detach the pCANVAS from the insertion system. In this case, the user must

carefully weigh the risks of a recovery (e.g. with a gripper instrument [Alligator Device, ev3/

Covidien/Medtronic]) against those of leaving the implant in the vessel.

•

Certiﬁ cation:

The instrument 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 pCANVAS. At least three (3) interventions using the pCANVAS must be supervised

by a physician or other qualiﬁ ed person delegated by phenox GmbH and their course and

outcome documented.

General Information

•

Keep away from heat. Store in a cool, dry place.

•

Use is only permissible before the expiration date, as sterility is not guaranteed otherwise.

•

Do not use if packaging is damaged, as sterility cannot be assumed otherwise.

•

The implant must not be resterilized or reprocessed for use on other patients, since it cannot

be reliably cleaned by the user.

•

The insertion system and, where necessary, packaging components must be disposed of

appropriately in marked containers.

Complications

The following complications, amongst others, may arise during or despite use of the pCANVAS:

•

Air embolism, embolism into distal vessels, thrombosis and cerebral ischemia

•

Perforation, rupture, dissection and other arterial lesions of the aneurysm and parent vessel

•

Vasospasm, occurrence of a pseudoaneurysm, intracranial hemorrhage

•

Bleeding at the puncture site, allergic reaction, infection

•

Space-occupying infarction, neurological deﬁ cit including all of the consequences of a

stroke, possibly with temporary care dependency

•

Pain and hemiplegia, disorders of movement and/or sensation, disorders of speech

comprehension and/or speech production, restriction of the ﬁ eld of vision, blindness,

reduction in the level of alertness (somnolence, stupor, coma), memory disorder (amnesia),

disorientation, neuropsychological disorders (e.g. neglect), persistent vegetative state, death

Magnetic resonance imaging

Non-clinical tests have shown that the pCANVAS is suitable for MRI at 3 T. Under clinical

conditions, the implant has proved to be unproblematic at a magnetic ﬂ ux density of 1.5 T.