The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess clinical safety and performance of the Concerto Versa™ Detachable Coils, when used in accordance with approved device labeling per the Instructions for Use (IFU). Data collected will generate clinical evidence to quantitatively assess clinical safety and device performance for the purpose of obtaining European Union Medical Device Regulation (EU MDR) approval.
Patient treated with Concerto Versa™ Detachable Coil is age ≥ 22 years at the time of procedure.
Use of Concerto Versa™ Detachable Coil in accordance with the device labeling.
Reporting of case within 72 hours of index procedure.
None
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.
Other
Prospective
Concerto Versa™ Detachable Coils
DeviceConcerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature
Rate of peri-procedural adverse events
The rate of peri-procedural adverse events related to device and/or procedure.
Rate of Technical Success
Technical success is defined as successful delivery and detachment of the coil, and removal of the delivery-pusher.
Rate of Peri-procedural success
Peri-procedural success is defined as ability of the device to successfully obstruct or reduce the rate of blood flow to the target lesion as determined by physician judgment.
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