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

Model Number	D-EVOLUTFX-34
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name evolut fx plus valve; product id evfxplus-34 (serial: (b)(6)); product type: 0195-heart valves; implant date (b)(6) 2025; the codes present in section h6 correspond to multiple components/products that comprise this reported event.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 the implant of a transcatheter valve in a patient with pre-existing pure aortic insufficiency (ai), following the third deployment attempt, the valve dislodged from the paddle attachment pocket and was subsequently recaptured.The delivery catheter system (dcs) was retrieved to the abdominal aorta and the valve was fully deployed.Subsequently, a second transcatheter valve was implanted in the aortic position.It was noted that the procedure was delayed approximately 1.5 hours as a result of the dislodge.Per the physician, the patient's pure ai contributed to the dislodge.
Additional Manufacturer Narrative
Updated: 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.
Event or Problem Description
It was reported that during the implant of a transcatheter valve in a patient with pre-existing pure aortic insufficiency (ai), following the third deployment attempt, the valve dislodged from the paddle attachment pocket and was subsequently recaptured.The delivery catheter system (dcs) was retrieved to the abdominal aorta and the valve was fully deployed.Subsequently, a second transcatheter valve was implanted in the aortic position.It was noted that the procedure was delayed approximately 1.5 hours as a result of the dislodge.Per the physician, the patient's pure ai contributed to the dislodge.Additional information was received that a medtronic (confida) guidewire was used for the procedure.The deployment starting point was at the bottom of the pigtail catheter.During the first deployment attempt, the position was too shallow and the valve was recaptured.On the second deployment attempt, the valve was positioned too deeply, and was recaptured.During the third deployment attempt, the valve dislodged into the aorta necessitating a third recapture, but it was then noticed that likely one valve paddle was not connected with the attachment pockets anymore, and only a partial recapture was possible.

• 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: 22998884
• Report Number: 9612164-2025-04431
• Device Sequence Number: 9413425
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)260114(10)0012111113
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2026
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012111113
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/03/2025
• Date Device Manufactured: 01/15/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male