MVP-9Q

MVP™ micro vascular plug system family with catheters shown horizontally in four sizes

Indications, Safety, and WarningsMRI Safety InformationNote: Safety information provided is for the United States. Please refer to your region’s instructions for use for specific details.Reference statementImportant information: Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.Indications for use: The MVP™ micro vascular plug system is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.Caution: Federal law (United States) restricts these devices to sale, distribution, and use by or on the order of a physician. Potential complicationsPotential adverse events that may occur during or after a procedure placing this device include, but are not limited to:Air embolus, allergic reaction/toxic effects, bleeding, death, device migration, fever, foreign material embolic event, infection, occlusion of unintended vessel, peripheral embolism, recanalization, residual flow, stroke/TIA, surgical intervention, vascular access site complication, vessel trauma/perforation.FTSOP113326-44 Rev. 1B
UC202114284-01ENMRI safety and compatibilityThe MVP™ micro vascular plug was determined to be MR conditional. Nonclinical testing demonstrated that the MVP™ micro vascular plug device is MR conditional. A patient with this device can be scanned safely, immediately after placement under the following conditions:

Static magnetic field of 3 Tesla or less

Maximum spatial gradient magnetic field of 9,000 Gauss/cm or less

Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of scanning (i.e., per pulse sequence)

First Level Controlled Operating Mode for the MR system

UC202602827 EN

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