MAUDE Adverse Event Report: MEDTRONIC IRELAND 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	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id evfxplus-29 (serial: (b)(6)); product type: 0195-heart valves; implant date n/a; explant date n/a.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 attempted implant of a 29 millimeter (mm) transcatheter valve in a patient with pre-existing severe aortic insufficiency and no leaflet calcification, the deployment of the valve was attempted 3 times.Prior to final deployment on each deployment attempt, the valve dislodged.Prior to valve dislodgement, the implant depth on the non-coronary cusp (ncc) was 5 mm, and the implant depth on the left coronary cusp (lcc) was 6 mm.Subsequently, the valve was withdrawn from the patient and was upsized to a 34 mm transcatheter valve.The 34 mm valve was successfully implanted at an implant depth of 5 mm on the ncc and 8 mm on the lcc.Per the physician, the patient's anatomy and aortic insufficiency caused the valve to dislodge.Following the implant procedure, the incorrect valve serial number was provided to the patient on their identification (id) card, with two aortic valves registered to the patient.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Updated data: b5.Added second paragraph.D3.D4.H4.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 attempted implant of a 29 millimeter (mm) transcatheter valve in a patient with pre-existing severe aortic insufficiency and no leaflet calcification, the deployment of the valve was attempted 3 times.Prior to final deployment on each deployment attempt, the valve dislodged.Prior to valve dislodgement, the implant depth on the non-coronary cusp (ncc) was 5 mm, and the implant depth on the left coronary cusp (lcc) was 6 mm.Subsequently, the valve was withdrawn from the patient and was upsized to a 34 mm transcatheter valve.The 34 mm valve was successfully implanted at an implant depth of 5 mm on the ncc and 8 mm on the lcc.Per the physician, the patient's anatomy and aortic insufficiency caused the valve to dislodge.Following the implant procedure, the incorrect valve serial number was provided to the patient on their identification (id) card, with two aortic valves registered to the patient.No patient complications were reported as a result of this event.Additional information was received indicating that the bottom of pigtail deployment starting position was used.The valve dislodged in the aortic direction to a depth of +5 mm on the ncc and lcc.Of note, a non-medtronic guidewire was used.

• Brand Name: EVOLUT FX DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway CA ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway CA ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22534129
• Report Number: 2025587-2025-05094
• Device Sequence Number: 18010732
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)270318(10)0012721946
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/15/2025

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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 102 KG