Indication For Use
The Penumbra Delivery Microcatheters are indicated 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.
Contraindications
There are no known contraindications.
Warnings
• The Penumbra Delivery Microcatheters should only be used by physicians who have received appropriate training in interventional techniques.
Precautions
• The devices are intended for single use only. Do not resterilize or reuse. Resterilization and/or Reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target location.
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer / distributor.
• Use prior to the “Use By” date.
• Use the Penumbra Delivery Microcatheters in conjunction with fluoroscopic visualization.
• Do not advance or withdraw the Penumbra Delivery Microcatheters against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Moving or torquing the device against resistance may result in damage to the vessel or device.
• Maintain a constant infusion of appropriate flush solution.
• If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
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
Indication For Use
Penumbra System® Reperfusion Catheters and Separators
As part of the Penumbra System®, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX™.
Contraindications
There are no known contraindications.
Warnings
• The Penumbra System should only be used by physicians who have received appropriate training in interventional neuro-endovascular techniques and treatment of acute ischemic stroke.
• Do not advance, retract or use any component of the Penumbra System against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device or system as a unit. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel.
• Do not use the Penumbra System with a pump other than the Penumbra Aspiration Pump.
Precautions
• The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or Reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target neuro vasculature location.
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor.
• Use prior to the “Use By” date.
• Use the Penumbra System in conjunction with fluoroscopic visualization.
• Maintain a constant infusion of appropriate flush solution.
• When performing aspiration, ensure the Penumbra Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Excessive aspiration or failure to close the Penumbra Aspiration Tubing valve when aspiration is complete is not recommended.
• The Penumbra Separator is not intended for use as a neurovascular guidewire. If repositioning of the Penumbra Reperfusion Catheter is necessary during the revascularization procedure, such reposition should be performed over an appropriate neurovascular guidewire using standard microcatheter and guidewire techniques.
• Do not use automated high-pressure contrast injection equipment with the Penumbra Reperfusion Catheter because it may damage the device.
• Administration of anticoagulants and antiplatelets should be suspended until 24 hours post-treatment. Medical management and acute post stroke care should follow the ASA guidelinesi. Any neurological deterioration should be evaluated by urgent CT scan and other evaluations as indicated according to investigator/hospital best practice.
• The total time allowed to achieve patient revascularization is 120 minutes of using the Penumbra System.
• As in all surgical interventions, monitoring of intra-procedural blood loss is recommended so that appropriate management may be instituted.
• Limit the usage of Reperfusion Catheters in arteries larger than the catheter’s outer diameter.
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
i Adams et al., Guidelines for the Early Management of Adults with Ischemic Stroke: A Guideline from the AHA/ASA Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Artherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists, Stroke May 2007; 38: 1655-1711.