MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
|
Back to Search Results |
|
Model Number EVOLUTFX-23 |
Device Problems
Gradient Increase (1270); Device Dislodged or Dislocated (2923); Activation Failure (3270)
|
Event Date 11/24/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Medtronic received information that during implant of this transcatheter bioprosthetic valve, after valve implantation and a post-implant balloon aortic valvuloplasty (bav), the valve dislodged.Although the coronary artery did not occlude, the st decreased over time and coronary blood flow was believed to be partially inhibited.The valve was therefore grasped from the radial artery using a snare, and pulled up to the ascending aorta.Afterwards, a second valve was placed and surgical bail-out was performed.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Additional information was received that no pre-balloon aortic valvuloplasty (bav) was performed.A post bav was performed because the pressure differential was more than 15 mmhg and the valve inflow strut was suspected to not be fully expanded.The deployment started at the bottom of the pigtail catheter.Prior to dislodgement, the valve implant depth was 2 mm on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc).
|
|
Search Alerts/Recalls
|
|
|