MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVOLUTFX-34
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that prior to the attempted implant of this transcatheter bioprosthetic valve, a pre-implant balloon aortic valvulop lasty was performed due to calcification.Following initial deployment, the valve was recaptured as the valve was placed too shallow and it dislodged in the aortic direction.Upon recapture, an infold was observed in the valve frame at a depth of approximately 3 mm to 5 mm.A second deployment attempt was made, but the valve was positioned too deep.Subsequently, the valve was recaptured and withdrawn from the patient.A new valve was loaded into a new delivery catheter system and successfully implanted in the patient.There was a 5-minute procedural delay.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Updated data: b5.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 or Problem Description
Additional information was received that indicated a pre-implant balloon dilation was not performed.Upon recapture following the second deployment attempt, the infold was observed.It was noted that the patient had calcified anatomy which made it difficult to properly seat the valve.The deployment starting point was at the bottom of the pigtail catheter.After valve dislodgement, the implant depth on the non-coronary cusp (ncc) was 4 mm and the implant depth on the left coronary cusp (lcc) was 6 mm.A non-medtronic guidewire was used during the procedure.

• Brand Name: EVOLUT FX DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22480824
• Report Number: 2025587-2025-04941
• Device Sequence Number: 12928756
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)260416(10)0012228739
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2026
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012228739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/04/2025
• Date Device Manufactured: 04/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male