POD System – Intended Use
For POD Coils with nominal sizes ≤ 6 mm – Intended Use
The POD System is intended for the embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature
For POD Coils with nominal sizes > 6 mm – Intended Use
The POD System is intended for arterial and venous embolizations in the peripheral vasculature.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
acute occlusion; air embolism; allergic reaction and anaphylaxis from contrast media; aneurysm rupture; arteriovenous fistula; coagulopathy; coil herniation into parent vessel; death; device malfunction; distal embolization; emboli; embolic stroke and other cerebral ischemic events; false aneurysm formation; hematoma or hemorrhage at access site of entry; incomplete aneurysm occlusion; infection; intima dissection; intracranial hemorrhage; ischemia; myocardial infarction; neurological deficits including stroke; parent artery occlusion; peripheral thromboembolic events; post-embolization syndrome; premature device detachment; recanalization; renal failure; respiratory failure; revascularization; thromboembolic episodes; vessel spasm, thrombosis, dissection, or perforation.
Penumbra Delivery Microcatheters – Intended Use
The Penumbra Delivery Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils to the peripheral and neuro vasculature.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
acute occlusion; hematoma or hemorrhage at access site; death; intracranial hemorrhage; hemorrhage; infection (at access site); distal embolization; ischemia (cardiac and/or cerebral); embolus (air, foreign body, thrombus, plaque); aneurysm perforation; false aneurysm formation; neurological deficits including stroke; vessel spasm, thrombosis, dissection, perforation or rupture; air embolism; emboli.
RUBY Coil System – Intended Use
The RUBY Coil System is intended for arterial and venous embolizations in the peripheral vasculature.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
acute occlusion; air embolism; allergic reaction and anaphylaxis from contrast media; aneurysm rupture; arteriovenous fistula; coagulopathy; coil herniation into parent vessel; death; device malfunction; distal embolization; emboli; embolic stroke and other cerebral ischemic events; false aneurysm formation; hematoma or hemorrhage at access site of entry; incomplete aneurysm occlusion; infection; intima dissection; intracranial hemorrhage; ischemia; myocardial infarction; neurological deficits including stroke; parent artery occlusion; peripheral thromboembolic events; post-embolization syndrome; premature device detachment; recanalization; renal failure; respiratory failure; revascularization; thromboembolic episodes; vessel spasm, thrombosis, dissection, or perforation.
