Merit Medical Embosphere Microspheres Sterile Vial IFU-Int'l: инструкция

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®

BioSphere

Medical

Instructions for use

Instructions d'utilisation

Gebrauchsanweisungen

Instrucciones de utilización

Istruzioni per l’uso

Instruções de utilização

Gebruiksaanwijzing

Brugsanvisning

Bruksanvisning

Käyttöohjeet

Instruksjoner for bruk

Οδηγίες χρήσης

Kullanma talimatları

Pokyny pro použití

Instrukcja stosowania

Instrucţiuni de utilizare

Инструкции за употреба

Használati útmutató

Lietošanas norādījumi

Naudojimo instrukcijos

Návod na použitie

Kasutusjuhised

Инструкции по применению

0459 - 2000

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ENGLISH

Do not use if the vial, screw cap or tray package appears damaged.

DESCRIPTION

®

Never reuse a vial that has been opened. All procedures must be

Embosphere

Microspheres are biocompatible, hydrophilic, non

performed according to an aseptic technique.

resorbable, precisely calibrated acrylic polymer microspheres

impregnated with porcine gelatin.

For single patient use only - Contents supplied sterile

They are available in a wide range of sizes and concentrations.

Do not reuse, reprocess, or resterilize. Reusing, reprocessing or

resterilizing may compromise the structural integrity of the device and

HOW SUPPLIED

or lead to device failure, which in turn may result in patient injury, illness

8 ml glass vial closed with screw-top cap, individually packaged in

®

or death. Reusing, reprocessing or resterilizing may also create a risk of

blister tray sealed by a peel-away Tyvek

lid.

contamination of the device and or cause patient infection or cross

Contents: 1 ml or 2 ml of microspheres in pyrogen-free, sterile, NaCl

infection including, but not limited to, the transmission of infectious

0,9% saline solution. Total volume of saline and microspheres: 5 ml.

disease(s) from one patient to another. Contamination of the device may

lead to injury, illness or death of the patient.

INDICATIONS

Embosphere Microspheres are designed to occlude blood vessels, for

WARNINGS

therapeutic or preoperative purposes, in the following procedures:

• Embosphere Microspheres contain gelatin of porcine origin, and,

− Embolization of hypervascular tumours and processes, including

therefore, could cause an immune reaction in patients who are

uterine fibroids, meningiomas, etc.

hypersensitive to collagen or gelatin. Careful consideration should be

− Embolization of arteriovenous malformations.

given prior to using this product in patients who are suspected to be

− Haemostatic embolization.

allergic to injections containing gelatin stabilizers.

40-120 µm microspheres are more specifically designed for

• Studies have shown that Embosphere Microspheres do not form

embolization of meningiomas and hepatic tumours.

aggregates, and as a result, penetrate deeper into the vasculature as

compared to similarly sized PVA particles. Care must be taken to choose

CONTRAINDICATIONS

larger sized Embosphere Microspheres when embolizing arteriovenous

− Patients unable to tolerate vascular occlusion procedures.

malformations with large shunts to avoid passage of the spheres into

− Vascular anatomy precluding correct catheter placement.

the pulmonary or coronary circulation.

− Feeding arteries too small to accept the selected microspheres.

• Some of the Embosphere Microspheres may be slightly outside of the

− Presence or suspicion of vasospasm.

range, so the physician should be sure to carefully select the size of

− Presence of distal arteries directly supplying cranial nerves.

Embosphere Microspheres according to the size of the target vessels at

− Presence of patent extra-to-intracranial anastomoses.

the desired level of occlusion in the vasculature and after consideration

− High-flow arteriovenous shunts or with a diameter greater than the

of the arteriovenous angiographic appearance. Embosphere

selected microspheres.

Microspheres size should be selected to prevent passage from artery to

− Pulmonary embolism.

vein.

− Severe atherosclerosis.

• Because of the significant complications of misembolization, extreme

− Patients with known allergy to gelatin.

caution should be used for any procedures involving the extracranial

40-120 µm and 100-300 µm microspheres are not recommended for

circulation encompassing the head and neck, and the physician should

use in the bronchial circulation.

carefully weigh the potential benefits of using embolization against the

risks and potential complications of the procedure. These complications

POTENTIAL COMPLICATIONS

can include blindness, hearing loss, loss of smell, paralysis and death.

Vascular embolization is a high-risk procedure. Complications may

• Serious radiation-induced skin injury may occur to the patient due to

occur at any time during or after the procedure, and may include, but

long periods of fluoroscopic exposure, large patient diameter, angled x-

are not limited to, the following:

ray projections, and multiple image recording runs or radiographs. Refer

− Stroke or cerebral infarction

to your facility’s clinical protocol to ensure the proper radiation dose is

− Occlusion of vessels of healthy territories

applied for each specific type of procedure performed. Physicians

− Vascular rupture and haemorrhage

should monitor patients that may be at risk.

− Neurological deficits

• Onset of radiation-induced injury to the patient may be delayed.

− Infection or haematoma at the injection site

Patients should be counseled on potential radiation side effects and

− Allergic reaction, cutaneous irritations

whom they should contact if they show symptoms.

− Transient pain and fever

• Pay careful attention for signs of mistargeted embolization. During

− Vasospasm

injection carefully monitor patient vital signs to include SAO2 (e.g.

− Death

hypoxia, CNS changes). Consider terminating the procedure,

− Ischemia at an undesirable location, including ischemic stroke,

investigating for possible shunting, or increasing microsphere size if any

ischemic infarction (including myocardial infarction), and tissue necrosis

signs of mistargeting occur or patient symptoms develop.

− Blindness, hearing loss, loss of smell, and/or paralysis

• Consider upsizing the microspheres if angiographic evidence of

− Additional information is found in the Warnings section

embolization does not quickly appear evident during injection of the

microspheres

CAUTION

Embosphere Microspheres must only be used by specialist physicians

Warnings about use of small microspheres

trained in vascular embolization procedures. The size and quantity of

• Careful consideration should be given whenever use is contemplated

microspheres must be carefully selected according to the lesion to be

of embolic agents that are smaller in diameter than the resolution

treated, entirely under the physician’s responsibility. Only the physician

capability of your imaging equipment. The presence of arteriovenous

can decide the most appropriate time to stop the injection of

anastomoses, branch vessels leading away from the target area or

microspheres.

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emergent vessels not evident prior to embolization can lead to

CONSERVATION AND STORAGE

mistargeted embolization and severe complications.

Embosphere Microspheres must be stored in a cool, dry, dark place in

• Microspheres smaller than 100 microns will generally migrate distal to

their original vials and packaging. Use by the date indicated on the labels

anastomotic feeders and therefore are more likely to terminate

of the outer box and blister's pack. Do not freeze.

circulation to distal tissue. Greater potential ischemic injury results from

use of smaller sized microspheres and consideration must be given to

the consequence of this injury prior to embolization. The potential

Size Range

Color Code 1 ml 2 ml

consequences include: swelling, necrosis, paralysis, abscess and/or

(µm)

stronger post embolization syndrome.

• Post-embolization swelling may result in ischemia to tissue adjacent to

40-120 Orange V110GH V120GH

target area. Care must be given to avoid ischemia-intolerant,

nontargeted tissue such as nervous tissue.

100-300 Yellow V210GH V220GH

INSTRUCTIONS

300-500 Blue V410GH V420GH

− Position the catheter at the desired site and perform baseline

angiography to evaluate the blood supply of the lesion.

500-700 Red V610GH V620GH

− Embosphere Microspheres are available in a range of sizes. Because

of the potential for misembolization and the inherent variability in sphere

sizes, the physician should be sure to carefully select the size of

700-900 Green V810GH V820GH

Embosphere Microspheres according to the size of the target vessels at

the desired level of occlusion in the vasculature.

900-1200 Purple V1010GH V1020GH

− Carefully select the size of microspheres according to the size of the

vessels identified and the catheter used. Embosphere Microspheres are

flexible particles that support temporary compression by 20 to 30 % to

Information on packaging:

facilitate passage through microcatheters. Studies have shown a direct

correlation between the size of microspheres and the size of occluded

Symbol

Designation

vessels.

− Check that the packaging is intact. The external surface of the vial is

Manufacturer: Name & Address

sterile.

− Gently swirl the opened vial, then pour into a sterile metal/stainless

Use by date: year-month

steel cup.

− It is highly recommended to add contrast agent to monitor the injection

LOT

Batch code

radiologically. Do not exceed a maximum proportion of 50 % contrast

REF

Catalogue number

agent – 50 % saline solution! To optimize diffusion of microspheres into

the territory to be embolized, it is recommended to use a fairly dilute

solution.

− To obtain a homogenous mixture, swirl the cup for about one minute.

Do not use the syringe or any other instrument to obtain the suspension,

as this could damage Embosphere Microspheres.

− Draw up the suspension using a small syringe (1 to 3 cc). Check that

the desired quantity and concentration of microspheres are used.

− Under continuous fluoroscopic control, slowly infuse microspheres into

the blood stream. Always inject under free flow conditions. Reflux of

microspheres can induce immediate ischemia of healthy tissues or

vessels.

− Continue infusion until the desired devascularization is obtained.

Studies have shown that Embosphere Microspheres penetrate more

distally into the lesion than PVA particles of similar size. Reduction of the

arterial blood supply to the lesion is therefore more progressive.

− At the end of the infusion, remove the catheter while maintaining

gentle aspiration to avoid dislodging any residual microspheres still

inside the catheter.

− Discard any open vial or unused Embosphere Microspheres.

All serious or life threatening adverse events or deaths associated

with use of Embosphere Microspheres should be reported to the

device manufacturer.

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Do not resterilize

Do not use if package is damaged

Keep away from sunlight

Keep dry

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Do not re-use

Caution - Refer to Instructions For Use

Non-pyrogenic

STERILE

Sterilized using steam

0°C

Lower limit of temperature

EC mark logo - Notified body identification : 0459