PC400^™ System

Penumbra Coil System – Intended Use
The Penumbra Coil System is intended for the endovascular embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• 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; death; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at puncture/access site/site of entry; infection; intracranial hemorrhage; ischemia; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; thromboembolic episodes; neurological deficits including stroke and possibly death; vascular thrombosis; post-embolization syndrome; revascularization; recanalization; inadequate occlusion; aneurysm rupture; parent artery occlusion; incomplete aneurysm filling.

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 agents, 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.