Merit Medical Syringe IFU-US User Manual [en, es, fr]

Medical

BioSphere

®

Instructions for use English 3

Instructions d'utilisation Français (French) 6

Instruções de utilização Português (Portuguese) 9

Instrucciones de utilización Español (Spanish) 12

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ENGLISH

EmboGold®Microspheres in a Prefilled Syringe - For Embolization

CAUTION: Federal (U.S.A.) law restricts this device to use by
or on the order of a licensed physician.

INTENDED USE :

• Embolization of hypervascularized tumors.

• Embolization of arteriovenous malformations (AVM).

CLINICAL APPLICATIONS :

Scientific literature provides extensive documentation of
embolization procedures using a wide variety of agents in both the
neurological and peripheral circulatory systems,including the head,
neck, spine, liver, genitourinary tract, uterus, gastrointestinal
system, limbs, and lungs. A representative bibliography of this
literature is provided following these instructions for use.

DESCRIPTION :

EmboGold Microspheres are part of a family of new embolic
materials based on BioSphere Medical’s proprietary microsphere
technology. These colored spheres are designed to add easy
visualization during handling, while still offering the controlled,
targeted embolization characteristics of the first microsphere
product, Embosphere® Microspheres.
EmboGold Microspheres are biocompatible, hydrophilic, non­resorbable, precisely calibrated microspheres produced from an
acrylic polymer and impregnated with porcine gelatin. EmboGold
Microspheres are available in a range of sizes.

DEVICE PACKAGING :

• Embolic contained in sterile, 20 mL syringe (pre-filled syringe),
packaged in a peel-away tray.

• Each syringe contains approximately 1.0 mL or 2.0 mL of
EmboGold Microspheres in pyrogen-free, sterile, physiological
saline.

CONTRAINDICATIONS :

• Patients intolerant to occlusion procedures

• Vascular anatomy or blood flow that precludes catheter
placement or embolic agent injection.

• Presence or likely onset of vasospasm.

• Presence or likely onset of hemorrhage.

• Presence of severe atheromatous disease.

• Presence of feeding arteries smaller than distal branches from
which they emerge.

• Presence of patent extra-to-intracranial anastomoses or shunts.

• Presence of collateral vessel pathways potentially endangering
normal territories during embolization.

• Presence of end arteries leading directly to cranial nerves.

• Presence of arteries supplying the lesion not large enough to
accept EmboGold Microspheres.

• Vascular resistance peripheral to the feeding arteries precluding
passage of EmboGold Microspheres into the lesion.

• Do not use EmboGold Microspheresin the following applications:
a. Embolization of large diameter arteriovenous shunts (i.e. where
the blood does not pass through an arterial/capillary/venous
transition but directly from an artery to a vein).
b. In the pulmonary arterial vasculature.
c. Use in any vasculature where EmboGold Microspheres could
pass directly into the internal carotid artery, vertebral artery,
intracranial vasculature or the above-listed vessels.

• Patients who have an allergic response to gold.

WARNINGS:

• EmboGold Microspheres contain gelatin of porcine origin, and,
therefore, could cause an immune reaction in patients who are
hypersensitive to collagen or gelatin.Careful consideration should
be given prior to using this product in patients who are suspected
to be allergic to injections containing gelatin stabilizers.

• Studies have shown that EmboGold Microspheres do not form
aggregates, and as a result, penetrate deeper into the vasculature
as compared to similarly sized PVA particles. Care must be taken
to choose larger sized EmboGold Microspheres when embolizing
arteriovenous malformations with large shunts to avoid passage
of the spheres into the pulmonary or coronary circulation.

• Some of the EmboGold Microspheres may be slightly outside of
the range, so the physician should be sure to carefully select the
size of EmboGold Microspheres according to the size of the target
vessels at the desired level of occlusion in the vasculature and after
consideration of the arteriovenous angiographic appearance.
EmboGold Microspheres size should be selected to prevent
passage from artery to vein.

• Because of the significant complications of misembolization,
extreme caution should be used for any procedures involving the
extracranial circulation encompassing the head and neck, and the
physician should carefully weigh the potential benefits of using
embolization against the risks and potential complications of the
procedure. These complications can include blindness, hearing
loss, loss of smell, paralysis and death.

• The color of theEmboGold Microspherescould be visible through
the skin if injected into arteries feeding superficial tissues.

• Serious radiation-induced skin injury may occur to the patient
due to long periods of fluoroscopic exposure, large patient
diameter, angled x-ray projections, and multiple image recording
runs or radiographs. Refer to your facility’s clinical protocol to
ensure the proper radiation dose is applied for each specific type
of procedure performed. Physicians should monitor patients that
may be at risk.

• Onset of radiation-induced injury to the patient may be delayed.
Patients should be counseled on potential radiation side effects
and whom they should contact if they show symptoms.

• EmboGold Microspheres are not cleared for usein uterine fibroid
embolization and are associated with delayed pain and/or rash
when used in these procedures.

• Pay careful attention for signs of mistargeted embolization.
During injection carefully monitor patient vital signs to include
SAO2 (e.g. hypoxia, CNS changes). Consider terminating the
procedure, investigating for possible shunting, or increasing
microsphere size if any signs of mistargeting occur or patient
symptoms develop.

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• Consider upsizing the microspheres if angiographic evidence of
embolization does not quickly appear evident during injection of
the microspheres.

Warnings about use of small microspheres

• Careful consideration should be given whenever use is
contemplated of embolic agents that are smaller in diameter than
the resolution capability of your imaging equipment. The presence
of arteriovenous anastomoses, branch vessels leading away from
the target area or emergent vessels not evident prior to
embolization can lead to mistargeted embolization and severe
complications.

• Microspheres smaller than 100 microns will generally migrate
distal to anastomotic feeders and therefore are more likely to
terminate circulation to distal tissue. Greater potential ischemic
injury results from use of smaller sized microspheres and
consideration must be givento the consequence of thisinjury prior
to embolization. The potential consequences include: swelling,
necrosis, paralysis, abscess and/or stronger post embolization
syndrome.

• Post-embolization swelling may result in ischemia to tissue
adjacent to target area. Care must be given to avoid ischemia­intolerant, nontargeted tissue such as nervous tissue.

PRECAUTION :

• Do not use if the syringe, plunger seal or tray package appears
damaged.

• For single patient use only - Contents supplied sterile - Never
reuse, reprocess, or resterilize the contents of a syringe that has
been opened. Reusing, reprocessing or resterilizing may
compromise the structural integrity of the device and or lead to
device failure, which in turn may result in patient injury, illness or
death. Reusing, reprocessing or resterilizing may also create a risk
of contamination of the device and or cause patient infection or
cross infection including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of
the device may lead to injury,illness or death of the patient.

All procedures must be performed according to accepted aseptic

technique.

• Do not connect the 20 mL syringe with EmboGold Microspheres
directly to a microcatheter for embolic delivery, as a catheter
occlusion may result.

• The syringe is intended for embolic use only. Do not use for
another application.

• Select the size and quantity of EmboGold Microspheres
appropriate for the pathology to be treated.

• Embolization with EmboGold Microspheres should only be
performed by physicians who have received appropriate
interventional occlusion training in the region intended to be
embolized.

• Patients with known allergy to contrast medium may require
corticosteroids prior to embolization.

• Additional evaluations or precautions may be necessary in
managing periprocedural care for patients with the following
conditions :
– Bleeding diathesis or hypercoagulative state
– Immunocompromise.

POTENTIAL COMPLICATIONS :

Vascular embolization is a high-risk procedure. Complications may
occur at any time during or after the procedure, and may include,
but are not limited to, the following:

• Paralysis resulting from untargeted embolization or ischemic
injury from adjacent tissue edema.

• Undesirable reflux or passage of EmboGold Microspheres into
normal arteriesadjacentto the targeted lesion or through the lesion
into other arteries or arterial beds, such as the internal carotid
artery, pulmonary, or coronary circulations.

• Pulmonary Embolism due to arterial venous shunting.

• Ischemia at an undesirable location, including ischemic stroke,
ischemic infarction (including myocardial infarction), and tissue
necrosis.

• Capillary bed occlusion and tissue damage.

• Vessel or lesion rupture and hemorrhage.

• Neurological deficits, including cranial nerve palsies.

• Vasospasm.

• Death.

• Recanalization.

• Foreign body reactions necessitating medical intervention.

• Infection necessitating medical intervention.

• Clot formation at the tip of the catheter and subsequent
dislodgment.

• Allergic response to gold.

• Complications related to catheterization (e.g., hematoma at the
site of entry, clot formation at the tip of the catheter and
subsequent dislodgment, and nerve and/or circulatory injuries,
which may result in leg injury).

• Allergic reaction to medications (e.g. analgesics).

• Allergic reaction to contrast media or embolic material.

• Pain and/or rash, possibly delayed fromthe time of embolization.

• Blindness,hearing loss, loss of smell.

• Additional information is found in the Warnings section.

STORAGE AND STERILITY :

Inspect packaging prior to use to ensure seal integrity for
maintenance of sterility.

• EmboGold Microspheres must be stored in a cool, dry and dark
place in their original syringe and packaging.

• Use by the date indicated on the syringe label.

• Do not freeze.

• Do not resterilize.

INSTRUCTIONS FOR USE :

• Carefully evaluate the vascular network associated with the
lesion using high resolution imaging prior to beginning the
embolization procedure.

• EmboGold Microspheres are available in a range of sizes.
Because of the potential for misembolization and the inherent
variability in sphere sizes,thephysician should be sure to carefully
select the size of EmboGold Microspheres according to the size of
the target vessels at the desired level of occlusion in the
vasculature.

• When embolizing arteriovenous malformations (AVM),choose an
EmboGold Microspheres size that will occlude the nidus without
passing through the AVM.

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• Choose a delivery catheter based on the size of the target vessel

S

TERILIZE

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STERILE

and the microsphere size being used.EmboGold Microspheres can
tolerate temporary compression of up to 33% in order to facilitate
passage through the delivery catheter.

• EmboGold Microspheres are not radiopaque. It is recommended
that the embolization be monitored using fluoroscopic visualization
by adding the appropriate amount of contrast medium to the
physiologic saline suspension fluid.

• To deliver EmboGold Microspheres:
Match the total volume in the syringe with the same volume of
undiluted contrast, which will result in a 50% microsphere/saline
and 50% contrast solution. Remove all air from the syringe. To
evenly suspend the EmboGold Microsphere/contrast solution,
gently invert the 20mL syringe several times. Attach the 20mL
syringe to one port of the luer-lock 3-way stopcock; attach a 1mL
or 3mL injection syringe to another port on the stopcock, and, if
desired, a delivery catheter may be attached to the remaining port
on the stopcock. Wait several minutes to allow the EmboGold
Microspheres to suspend properly. Draw EmboGold
Microsphere/contrast solution into theinjection syringe slowly and
gently to minimize the potential of introducing air into the system.
Purge all air fromthe system prior to injection. Inject the EmboGold
Microsphere/ contrast solution under fluoroscopicvisualizationwith
the injection syringe, using a slow pulsatile injection, while
observing the contrast flow rate. If there is no effect on the flow
rate, repeat the delivery process with additional injections of
EmboGold Microsphere/contrast solution,or larger sized EmboGold
Microspheres may be considered. If the EmboGold
Microsphere/contrast solution requires resuspension, gently invert
the 20mL syringe several times. Exercise conservative judgment in
determining the embolization endpoint.

• Femoral puncture can result in arterial spasm. This may
predispose to femoral thrombosis (e.g. leg injury). Femoral patency
should be re-assessed prior to final catheter removal.

• Upon completion of the treatment, remove the catheter while
maintaining gentle suction so as not to dislodge EmboGold
Microspheres still within the catheter lumen.

• Apply pressure to the puncture siteuntil hemostatis is complete.

• Discard any open, unused EmboGold Microspheres.

REFERENCES :

1. Bendszus M, Klein R,Burger R, et al.: Efficacy of trisacryl gelatin
microspheresversuspolyvinylalcoholparticles in the preoperative
embolization of meningiomas. AJNR, 21(2):255-61, Feb 2000.

2. Deveikis JP: Endovascular therapy of intracranial arteriovenous
malformations: materials and techniques. Neuroimaging Clin of N
Am, 8(2):401-424, 1998.

3. Frizzel RT, Fisher WS: Cure, morbidity, and mortality associated
with embolization of brain arteriovenous malformations: A review
of 1246 patients in 32 series over a 35-year period. Neurosurg,
37(6):1031-1040, Dec 1995.

4. Gomes, A: Embolization therapy of congenital arteriovenous
malformations;Use of alternative approaches.Radiology,190:191­8, Jan 1994.

5.Terada,T; Kinoshita,Y; Yokote, H; Tsuura, M; Itakura, T;Komai,N;
Nakamura,Y;Tanaka,S; Kuriyama, T:Preoperative embolization of
meningiomas fed by ophthalmic branch arteries. Surg Neurol,
45:161-6, 1996.

Information on packaging :

Symbol Designation

Manufacturer: Name & Address

Use by date: year-month

LOT

REF

Batch code

Catalogue number

Do not resterilize

Do not use if package is damaged

Keep away from sunlight

Keep dry

Do not re-use

Caution - Refer to Instructions For Use

Non-pyrogenic

Sterilized using steam

0°C

Lower limit of temperature

Distributed in USA by:

Merit Medical Systems, Inc.
Customer Service 1-800-356-3748

781-681-7900

Patent Information

US 5,635,215 and other patent(s) issued and pending.

EmboGold Microspheres is a registered trademark of BioSphere
Medical.

All serious or life-threatening adverse events or deaths associated
with use of EmboGold Microspheres should be reported to the U.S.
Food and Drug Administrationunderthe MedWatchprogramand to
the device manufacturer.Information about the MedWatch program
and forms for reporting adverse events can be obtained at
www.fda.gov/safety/medwatch/howtoreport/ucm053074.htm or
by calling toll free 888-463-6332. Reports to BioSphere Medical,
Inc. can be made by calling toll free 800-394-0295.

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