Merit Medical EmboGold Microspheres IFU-Int'l - Manual (Page 3)

DESCRIPTION
EmboGold® Microspheres are biocompatible, hydrophilic,
non-absorbable, precisely calibrated acrylic polymer
microspheres impregnated with porcine gelatin and are
available in a large range of sizes and concentrations.
EmboGold Microspheres are coloured to facilitate visualisation
during handling.
HOW SUPPLIED
20-ml prefilled syringe with a standard Luerlock tip,
individually packaged in blister tray sealed by a Tyvek
® peel-
away lid. Plastic screw cap and plunger. Elastomer three-skirt
plunger joint.
Contents: 1 ml or 2 ml of microspheres in sterile, pyrogen-
free, 0.9% NaCl solution.
INDICATIONS
EmboGold Microspheres are designed to occlude blood
vessels, for therapeutic or preoperative purposes, in the
following procedures:
– Embolisation of hypervascular tumours and processes,
including uterine fibroids, meningiomas,etc.
– Embolisation of arteriovenous malformations.
– Haemostatic embolisation.
40-120 µm microspheres are more specifically designed for
embolisation of meningiomas and liver tumours.
CONTRAINDICATIONS
− Patients unable to tolerate vascular occlusion procedures.
− Vascular anatomy precluding correct catheter placement.
− Feeding arteries too small to accept the selected
microspheres.
− Presence or suspicion of vasospasm.
− Presence of distal arteries directly supplying cranial nerves.
− Presence of patent extra-to-intracranial anastomoses.
− High-flow arteriovenous shunts or with a diameter greater
than the selected microspheres.
− Pulmonary embolism.
− Severe atherosclerosis.
− Patients with known allergy to gelatin and/or gold.
40-120 µm and 100-300 µm microspheres are not
recommended for use in the bronchial circulation.
POTENTIAL COMPLICATIONS
Vascular embolisation 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:
– Stroke or cerebral infarction
– Occlusion of vessels in healthy territories
– Vascular rupture and haemorrhage
– Neurological deficits
– Infection or haematoma at the injection site
– Allergic reaction, cutaneous irritations
– Transient pain and fever
– Vasospasm
– Death
– Ischemia at an undesirable location, including ischemic
stroke, ischemic infarction (including myocardial infarction),
and tissue necrosis
– Blindness, hearing loss, loss of smell, and/or paralysis
– Additional information is found in the Warnings section
CAUTION
DO NOT USE THIS PREFILLED SYRINGE TO DIRECTLY
INJECT
EMBOGOLD MICROSPHERES. THIS IS A
“RESERVOIR” SYRINGE. PLEASE REFER TO INSTRUCTIONS
PARAGRAPH.
EmboGold Microspheres must only be used by specialist
physicians trained in vascular embolisation procedures. The
size and quantity of microspheres must be carefully selected
according to the lesion to be treated, entirely under the
physician’s responsibility. Only the physician can decide the
most appropriate time to stop the injection of microspheres.
Do not use if blister tray, peel-away film, screw cap or syringe
are damaged. This is a disposable product. Discard opened
syringes after use. All procedures must be performed
according to an aseptic technique.
For single patient use only - Contents supplied sterile
Do not reuse, reprocess, or resterilize. 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.
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.
• The color of the EmboGold Microspheres could be visible
through the skin if injected into arteries feeding superficial
tissues.
• 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.
• 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.
• 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.
• Consider upsizing the microspheres if angiographic evidence
of embolization does not quickly appear evident during injection
of the microspheres
ENGLISH
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