Merit Medical Embosphere Gebrauchsanweisungen Seite 6

• 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 embolisation.
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
embolisation does not quickly appear evident during injection
of the microspheres
Warnings about use of small microspheres
• Careful consideration should be given whenever use is contem-
plated 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
embolisation can lead to mistargeted embolisation 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 ischaemic
injury results from use of smaller sized microspheres and consid-
eration must be given to the consequence of this injury prior to
embolisation. The potential consequences include: swelling,
necrosis, paralysis, abscess and/or stronger post embolisation
syndrome.
• Post-embolisation swelling may result in ischaemia to tissue ad-
jacent to target area. Care must be given to avoid ischaemia-in-
tolerant, nontargeted tissue such as nervous tissue.
INSTRUCTIONS
• Position the catheter at the desired site and perform baseline
angiography to evaluate the blood supply of the lesion.
• Embosphere Microspheres are available in a range of sizes.
Because of the potential for misembolisation and the inherent
variability in sphere sizes, the physician should be sure to care-
fully select the size of Embosphere Microspheres according to
the size of the target vessels at the desired level of occlusion in
the vasculature.
• Carefully select the size of microspheres according to the size of
the vessels identified and the catheter used. Embosphere Micro-
spheres are flexible particles that support temporary compression
by 20 to 30 % to facilitate passage through microcatheters. Stud-
ies have shown a direct correlation between the size of micro-
spheres and the size of occluded vessels.
• Check that the packaging is intact. The external surface of the
vial is sterile.
• Gently swirl the opened vial, then pour into a sterile metal/
stainless steel cup.
• It is highly recommended to add contrast agent to monitor the
injection radiologically. Do not exceed a maximum proportion of
50 % contrast agent – 50 % saline solution! To optimize diffusion
of microspheres into the territory to be embolised, it is recom-
mended to use a fairly dilute solution.
• To obtain a homogenous mixture, swirl the cup for about one
minute. Do not use the syringe or any other instrument to obtain
the suspension, as this could damage Embosphere Microspheres.
• Draw up the suspension using a small syringe (1 to 3 cc). Check
that the desired quantity and concentration of microspheres are
used.
• Under continuous fluoroscopic control, slowly infuse micro-
spheres into the blood stream. Always inject under free flow con-
ditions. Reflux of microspheres can induce immediate ischaemia
of healthy tissues or vessels.
• Continue infusion until the desired devascularisation is obtained.
Studies have shown that Embosphere Microspheres penetrate
more distally into the lesion than PVA particles of similar size.
Reduction of the arterial blood supply to the lesion is therefore
more progressive.
• At the end of the infusion, remove the catheter while maintaining
gentle aspiration to avoid dislodging any residual microspheres
still inside the catheter.
• Discard any open vial or unused Embosphere Microspheres.
CONSERVATION AND STORAGE
Embosphere Microspheres must be stored in a cool, dry, dark place in
their original vials and packaging. Use by the date indicated on the
labels of the outer box and blister pack. Do not freeze.
Size Range
Minimum
Catheter ID Color Code
(μm)
0.016"
50-100
(0.41 mm)
0.016"
40-120
(0.41 mm)
0.017"
100-300
(0.43 mm)
0.018"
300-500
(0.46 mm)
0.020"
500-700
(0.51 mm)
0.027"
700-900
(0.69 mm)
0.038"
900-1200
(0.97 mm)
Information on packaging:
All serious or life threatening adverse events or deaths associated
with use of Embosphere Microspheres should be reported to the
device manufacturer.
6
1 mL
Grey V010GH V020GH
Orange V110GH V120GH
Yellow V210GH V220GH
Blue V410GH V420GH
Red V610GH V620GH
Green V810GH V820GH
Purple V1010GH V1020GH
2 mL