MEDTRONIC HEART VALVES DIVISION / COREVALVE, LLC. EVOLUT FX DELIVERY CATHETER SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
|
Back to Search Results |
|
Model Number D-EVOLUTFX-2329 |
Device Problems
Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
|
Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
|
Event Date 11/08/2022 |
Event Type
Injury
|
Event Description
|
Initial placement of transcatheter aortic valve went well with good position at 3 mm deep to the annulus.While retrieving the deployment device, the valve was snagged by the tip of the cone and jumped out of the annulus.We attempted placement of an additional transcatheter valve.On our third deployment attempt, the valve spontaneously deployed from the device landing 7 to 10 mm deep on the noncoronary cusp.This valve dove deep into the ventricle.Patient had moderate aortic regurgitation around the cage with hemodynamic lability.Patient underwent removal of trans catheter valve and surgical aortic valve replacement.Fda safety report id# (b)(4).
|
|
Search Alerts/Recalls
|
|
|