CV-5-30

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Indications, Safety, and WarningsMRI Safety InformationIndications for UseThe Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature. ContraindicationsThere are no known contraindications. Potential Adverse Effects of the Device on HealthThe potential complications include, but are not limited to the following: access site complications such as hematoma, hemorrhage, pain; death; device complications such as coil stretching, friction, fracture, breakage, migration, premature detachment, non-detachment; reaction to device materials such as hypersensitivity, fever, shock, foreign body reaction; systemic complications such as infection, pain, shock, fever, inflammation, toxicity, organ failure, nerve damage, necrosis, hypotention, hematoma, hemorrhagic complications, edema; thromboembolic complications such as ischemia, infarction, occlusion, embolism; incomplete or subtherapeutic response; vascular complications such as vasoconstriction, stenosis, dissection, perforation, fistula formation, occlusion.CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative.US-CV-2600919 v1.0MRI safety and compatibilityNon-clinical testing and electromagnetic/thermal modeling demonstrated that the Concerto Versa detachable coil is MR Conditional. A patient with this device can be safely scanned in an MR system that meets these conditions:

Static magnetic field of 1.5 T or 3 T only

Maximum spatial gradient magnetic field of 3000 gauss/cm (30 T/m) or less

Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 1 W/kg during operation for the MR system

Under the scan conditions defined above, the Concerto Versa detachable coil is expected to produce a maximum temperature rise of less than 6 °C after 15 min of continuous scanning.In non-clinical testing, the image artifact caused by the device extends approximately 7.2 mm from the Concerto Versa detachable coil when imaged with a gradient echo pulse sequence and a 3 T MRI system.US-CV-2600920 v1.0

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