ADAPT Distal Occlusion
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Risk Information
Product availability varies by country. The opinions and clinical experiences presented herein are for informational purposes only. The results may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors. Please contact your local Penumbra representative for more information.
Penumbra System – Intended Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease using continuous aspiration.
Potential Adverse Events
Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus;
infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; radiation exposure that may lead to cataracts, skin reddening or burns from x-ray exposure.
Penumbra ENGINE – Intended Use
The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems.
PENUMBRA SYSTEM – Intended Use
The PENUMBRA SYSTEM is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease using continuous aspiration.
Potential Adverse Events
Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus;
infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; radiation exposure that may lead to cataracts, skin reddening, burns, alopecia, or neoplasia from x-ray exposure.
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