English - Merit Medical Embosphere Gebrauchsanweisungen

ENGLISH

DESCRIPTION
Embosphere® Microspheres are biocompatible, hydrophilic, non
resorbable, precisely calibrated acrylic polymer microspheres im-
pregnated 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:
• Embolisation of hypervascular tumours and processes, including
uterine fibroids, meningiomas, etc.
• Embolisation of arteriovenous malformations.
• Haemostatic embolisation.
• Embolisation of the prostate arteries for relief of symptoms re-
lated to Benign Prostatic Hyperplasia.
40-120 μm microspheres are more specifically designed for emboli-
sation 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.
• Use in the pulmonary vasculature.
• Severe atherosclerosis.
• Patients with known allergy to gelatin.
50-100 μm, 40-120 μm and 100-300 μm microspheres are not rec-
ommended 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 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
• Ischaemia at an undesirable location, including ischaemic stroke,
ischaemic 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 phy-
sicians 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 responsibil-
ity. 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 resterilise. Reusing, reprocessing or rest-
erilising 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 resterilising may also cre-
ate a risk of contamination of the device and or cause patient infec-
tion 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 stabi-
lizers.
• 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 embolis-
ing arteriovenous malformations with large shunts to avoid pas-
sage 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 ap-
pearance. Embosphere Microspheres size should be selected to
prevent passage from artery to vein.
• Because of the significant complications of misembolisation,
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
embolisation against the risks and potential complications of the
procedure. These complications can include blindness, hearing
loss, loss of smell, paralysis and death.
• Because of the tortuous vessels and duplicative feeding arteries in
the pelvic area, extreme caution should be used when performing
embolisation for the treatment of symptomatic Benign Prostatic
Hyperplasia. Complications of misembolisation may include
ischaemia of the rectum, bladder, scrotum penis or other areas.
• Serious radiation-induced skin injury may occur to the patient
due to long periods of fluoroscopic exposure, large patient di-
ameter, 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.
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