Merit Medical Embosphere Microspheres Sterile Vial IFU-Int'l - Manual (Page 5)

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ENGLISH
DESCRIPTION
Embosphere
® Microspheres are biocompatible, hydrophilic, non
resorbable, precisely calibrated acrylic polymer microspheres
impregnated with porcine gelatin.
They are available in a wide range of sizes and concentrations.
HOW SUPPLIED
8 ml glass vial closed with screw-top cap, individually packaged in
blister tray sealed by a peel-away Tyvek
® lid.
Contents: 1 ml or 2 ml of microspheres in pyrogen-free, sterile, NaCl
0,9% saline solution. Total volume of saline and microspheres: 5 ml.
INDICATIONS
Embosphere Microspheres are designed to occlude blood vessels, for
therapeutic or preoperative purposes, in the following procedures:
− Embolization of hypervascular tumours and processes, including
uterine fibroids, meningiomas, etc.
− Embolization of arteriovenous malformations.
− Haemostatic embolization.
40-120
µm microspheres are more specifically designed for
embolization of meningiomas and hepatic 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.
40-120
µm and 100-300 µm microspheres are not recommended for
use in the bronchial circulation.
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:
− Stroke or cerebral infarction
− Occlusion of vessels of 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
Embosphere Microspheres must only be used by specialist physicians
trained in vascular embolization 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 the vial, screw cap or tray package appears damaged.
Never reuse a vial that has been opened. 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
• Embosphere 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 Embosphere 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 Embosphere Microspheres when embolizing arteriovenous
malformations with large shunts to avoid passage of the spheres into
the pulmonary or coronary circulation.
• Some of the Embosphere Microspheres may be slightly outside of the
range, so the physician should be sure to carefully select the size of
Embosphere 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. Embosphere
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.
• 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
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
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