SAVION DLVR™ and SAVION FLX™ Guidewires

INTENDED USE/INDICATIONS FOR USE

Boston Scientific SAVION DLVR and SAVION FLX Guidewires are intended to facilitate the placement of balloon dilatation catheters, stents or other interventional therapeutic devices during peripheral vascular interventional procedures. They are not intended for use in the coronary or cerebral vasculatur.

CONTRAINDICATIONS

None known.

WARNINGS

• Guidewires should be used only by physicians thoroughly trained in their intended use. Prior to the procedure, all equipment to be used for the procedure should be carefully examined to verify proper function and integrity. Surface irregularities, bends or kinks may decrease performance characteristics. 
• Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. 
• Do not attempt to move the wire without observing the resultant tip response.  
• Never advance the guidewire against resistance without first determining the reason for resistance under fluoroscopy. Do not rotate the guidewire if significant resistance is felt. Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter or vessel damage. 
• Exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking or coil separation. Resulting guidewire fractures might require additional percutaneous intervention or surgery. 
• The hydrophilic coating of these guidewires increases the possibility of vessel wall perforation compared to non-hydrophilic coatings. Maintain diligent control of the distal tip at all times during an intervention to avoid vessel dissections and perforations. 
• Care should be taken when advancing a guidewire after stent deployment. A guidewire may exits between stent struts when recrossing a stent that is not fully apposed to the vessel wall. Subsequent advancement of any device over the guidewire could cause entanglement between the guidewire and the stent.

POTENTIAL ADVERSE EVENTS

Potential adverse events which may result from the use of the device include but are not limited to:

• Abrupt closure
• Allergic reaction (to contrast, device or other)
• Bleeding/Hemorrhage
• Death
• Embolization (plaque, thrombus, device, tissue, or other)
• Hematoma
• Infection/Sepsis
• Ischemia
• Pain at the access site
• Pseudoaneurysm
• Renal insufficiency or renal failure
• Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)
• Thrombosis/Thrombus
• Vasospasm
• Vessel trauma (dissection, perforation, rupture or injury)

Some of the above potential adverse events may require additional urgent intervention or surgery.

92275338 Version C.4