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

Model Number	D-EVOLUTFX-2329
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	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Select patient information cannot be included in the regulatory report due to regional privacy regulations.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 during a transcatheter aortic valve procedure, the valve was deployed and recaptured a couple times and an infold was then identified.The valve was recaptured and removed and a new system was used for implant.Additional information was received indicating that the valve was recaptured twice during deployment due to dislodgments while attached to the delivery catheter system (dcs).There was a procedural delay as the implanting physicians had to wait for the new valve to be opened and prepared.Ofnote, the patient had two calcium spurs extending into left ventricular outflow tract that were approximately 11 mm from the basal plane.Aortic valve calcium measured at 725 mm cubed.
Additional Manufacturer Narrative
Updated: 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
It was reported that during a transcatheter aortic valve procedure, the valve was deployed and recaptured a couple times and an infold was then identified.The valve was recaptured and removed and a new system was used for implant.Additional information was received indicating that the valve was recaptured twice during deployment due to dislodgments while attached to the delivery catheter system (dcs).There was a procedural delay as the implanting physicians had to wait for the new valve to be opened and prepared.Ofnote, the patient had two calcium spurs extending into left ventricular outflow tract that were approximately 11 mm from the basal plane.Aortic valve calcium measured at 725 mm cubed.Additional information was received that a pre-implant balloon dilation was not performed.The deployment starting point was at the bottom of the pigtail catheter.Prior to valve dislodgement, the implant depth was -3 mm on the non-coronary cusp (ncc) and -4 mm on the left coronary cusp (lcc).The valve was in an unstable position and dislodged aortic for an unknown reason.When retrieved, the infold was observed.After the valve dislodgement, the final position of the second valve was -2 mm on the ncc and -4 mm on the lcc.Nothing specific about the patient anatomy contributed to the dislodgment, except for uneven calcium distribution most prominent on the ncc leaflet.
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.

• Brand Name: EVOLUT FX DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23016801
• Report Number: 9612164-2025-04484
• Device Sequence Number: 13196967
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)270709(10)0012912460
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0012912460
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 09/12/2025; 09/26/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 09/18/2025; 10/22/2025
• Date Device Manufactured: 07/09/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female