Neuroform3® Microdelivery Stent System (Humanitarian Use Device)

Neuroform3^® Microdelivery Stent System Prescriptive Information

See package insert for complete indications, contraindications, warnings, and instructions for use.

Indications for Use
Humanitarian Device. Authorized by Federal law for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than or equal to 2 mm and less than or equal to 4.5 mm that are not amenable to treatment with surgical clipping. Wide-neck aneurysms are defined as having a neck greater than or equal to 4 mm or a dome-to-neck ratio less than or equal to 2. The effectiveness of this device for this use has not been demonstrated.

Contraindications
Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.

Potential Adverse Effects
Potential complications include but are not limited to: aneurysm perforation or rupture; cerebral ischemia; coagulopathy; coil herniation through stent into parent vessel; confusion; death; embolic stroke; hematoma, pain and/or infection at access site; incomplete aneurysm occlusion; intimal dissection; intracerebral/intracranial hemorrhage; peripheral thromboembolic events; post-procedure bleeding; pseudoaneurysm formation; renal failure; stent migration; stent misplacement; stent occlusion; vasospasm; vessel perforation; vessel thrombosis.

Warnings

• The Neuroform Microdelivery Stent System should only be used by physicians who have received appropriate training in interventional neuroradiology and treatment of intracranial aneurysms.
• Select a stent size (length and diameter) to maintain a minimum of 4 mm on each side of the aneurysm neck along the parent vessel. An incorrectly sized stent may result in damage to the vessel or stent migration. Therefore, the stent is not designed to treat an aneurysm with a neck greater than 22 mm in length.
• The 3F microdelivery catheter or the 2F stabilizer catheter is not designed or intended for contrast injections.
• If excessive resistance is encountered during the use of the Neuroform Microdelivery Stent System or any of its components at any time during the procedure, discontinue use of the system. Movement of the system against resistance may result in damage to the vessel or a system component.

Precautions

• Federal Law (USA) restricts this device to sale by or on the order of a physician.
• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.
• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise structural integrity of the device and/or lead to device failure that, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization 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 death of the patient.
• Resale of this device is prohibited by law.

Cautions

• The Neuroform Microdelivery Stent System is provided STERILE for single use only. Store in a cool, dry place.
• Use Neuroform Microdelivery Stent System prior to the "Use Before" date printed on the package.
• Carefully inspect the sterile package and Neuroform Microdelivery Stent System prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.
• The Neuroform Microdelivery Stent System has been shown to be MRI compatible in MRI systems operating at field strength of 1.5 Tesla or less. MRI laboratory evaluation demonstrated that no significant image distortion or heating was created by the presence of the stents at scanning sequences commonly used during MRI procedures. MRI compatibility of the embolic coils used in conjunction with the stent has not been demonstrated by Boston Scientific; refer to the specific embolic coil labeling for MRI compatibility information.
• The Neuroform Microdelivery Stent System should not be used for repositioning or recapturing the stent.
• Exercise caution when crossing the deployed stent with adjunct devices.
• Do not excessively insert and retract the guidewire through the undeployed stent because the motion may remove coating from the guidewire.
• Tighten the rotating hemostasis valves sufficiently to create an adequate hemostasis seal without crushing the 3F microdelivery catheter and 2F stabilizer catheter shafts. Inadequately tightening the rotating hemostasis valves may lead to premature deployment of the stent.
• In tortuous vessels, a stiff guidewire may cause binding within the Neuroform Microdelivery Stent System during deployment. In such cases, use only soft guidewires, and position the floppy section of the guidewire within the stent.
• After deployment, the stent may foreshorten up to 1.8% in 2.5 mm stents and up to 5.4% in 4.5 mm stents.
• Do not steam shape the tip of the 3F microdelivery catheter because it could damage the delivery system or stent.
• The safety of the Neuroform Microdelivery Stent System in patients below the age of 18 has not been established.
• Testing on the 30 mm length stents and 3 interconnect stents was performed in the lab but not in animals or humans. However, probable benefit is still expected.