SAVION DLVR™ and SAVION FLX™ Guidewires
Indications, Safety and Warnings
Prescriptive Information
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 vasculature.
CONTRAINDICATIONS
None known.
WARNINGS
Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Severe reaction may occur in response to contrast agents that cannot be adequately premedicated.
When the guidewire is in the body, it should be manipulated only under fluoroscopy.
The hydrophilic coating of these guidewires increases the possibility of vessel wall perforation compared to non-hydrophilic coatings.
PRECAUTIONS
Carefully check and match therapeutic device compatibility to the wire prior to use.
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 B