Merit Medical Embosphere Microspheres Prefilled Syringe IFU-Int'l - Manual (Page 3)

DESCRIPTION
Embosphere® 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.
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
Embosphere 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.
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 EMBOSPHERE MICROSPHERES. THIS IS A
“RESERVOIR” SYRINGE. PLEASE REFER TO INSTRUCTIONS
PARAGRAPH.
Embosphere 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
• 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
SaO
2
(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 emergent vessels not
ENGLISH
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