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

Model Number	D-EVOLUTFX-34
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the implant of a 34 millimeter (mm) transcatheter valve, a pre-implant balloon aortic valvuloplasty was performed due to calcification which was standard for the implanting physician.Upon 80% deployment, the valve dislodged aortic and was subsequently recaptured.Upon the second deployment attempt at 80% deployment, an infold was observed.Subsequently, the valve was recaptured and withdrawn from the patient.A 29 mm transcatheter valve was used to complete the procedure.Per the physician, the patient's calcified anatomy and borderline pre-case measurements contributed to the infold/dislodge.It was noted that a 5 minute procedural delay occurred as a result of the infold/dislodge.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id: evfxplus-34 (k080373); product type: 0195-heart valves.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 the deployment starting point was at the bottom of the pigtail catheter.Prior to valve dislodgement, an implant depth of 2-3 mm was attempted, but at 80% deployment the temporary pacemaker was turned off and the valve dislodged aortic.Following dislodgement, the valve was well into the sinuses.A non-medtronic guidewire was use during the procedure.
Additional Manufacturer Narrative
Updated data: b5.H6.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.

• 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: 22544196
• Report Number: 2025587-2025-05149
• Device Sequence Number: 7000835
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)270318(10)0012721946
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/21/2025

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 Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012721946
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 03/18/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 105 KG