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Presence of severe atheromatous disease
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Presence of feeding arteries too small to accept the selected device
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Presence of collateral vessel pathways potentially endangering normal territories during
embolization
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Presence of arteries supplying the lesion not large enough to accept the selected size of
the device
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Vascular resistance peripheral to the feeding arteries precluding passage of the device
into the lesion
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In large diameter arteriovenous shunts (i.e. where the blood does not pass through an
arterial/capillary/venous transition but directly from an artery to a vein)
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In the pulmonary vasculature
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Coronary and intracerebral vascular use
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Presence of patent extra-to-intracranial anastomoses or shunts
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Presence of end arteries leading directly to cranial nerves
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In any vasculature where the device could pass directly into the internal carotid artery,
vertebral artery, intracranial vasculature or the above listed vessels
WARNINGS
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The Torpedo contains 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.
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The physician should be sure to carefully select the size of the Torpedo 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. Size should be selected to
prevent passage from artery to vein.
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Because of the significant complications of non-target embolization, 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.
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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.
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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.
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Pay careful attention for signs of non-targeted 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 the size of
the Torpedo if any signs of non-target embolization occur or patient symptoms develop.
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Consider upsizing the Torpedo if angiographic evidence of embolization does not quickly
appear evident during injection of the Torpedo device.
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Post embolization swelling may result in ischemia to tissue adjacent to target area. Care
must be given to avoid ischemia intolerant, non-targeted tissue such as nervous tissue.
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If air is not fully purged from the system prior to injection air embolism may occur.
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Torpedo Gelatin Foam should not be used in the neurovasculature.
PRECAUTIONS
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Do not use the Torpedo if the packaging is damaged.
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For single patient use only—contents supplied sterile—never reuse, reprocess or
resterilize the contents of the Torpedo packaging. 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
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