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); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the implant of a transcatheter aortic valve, a balloon aortic valvuloplasty was performed due to patient calcification.Upon 80% deployment of the valve, it was reported that the system dislodged aortic.The valve was subsequently recaptured.It was reported that dislodgement continued to occur multiple times at 80% deployment, so the system was withdrawn from the patient.Another pre-implant bav was performed due to the prior dislodgements.Upon 80% deployment of the second valve, it was determined that the positioning was too high relative to the target implant depth of 0-1 millimeters (mm) on the non-coronary cusp (ncc) and above the annular plane on the left coronary cusp (lcc), it was determined necessary to recapture the valve.Upon the attempted recapture, the deployment knob was turned too quickly, resulting in inadvertent deployment of the valve.The valve ultimately dislodged to above the sinotubular junction (stj) on the ncc and 1-2 mm below the stj on the lcc, resulting in embolization.Subsequently, the valve was snared into the ascending aorta.A third valve was opened and used to complete the procedure.It was reported that a 90 minute procedural delay occurred as a result.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e vfxplus-34, serial/lot #: (b)(6), ubd: 11-apr-2027, udi#: (b)(4).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 implant of a transcatheter aortic valve, a balloon aortic valvuloplasty was performed due to patient calcification.Upon 80% deployment of the valve, it was reported that the system dislodged aortic.The valve was subsequently recaptured.It was reported that dislodgement continued to occur multiple times at 80% deployment, so the system was withdrawn from the patient.Another pre-implant bav was performed due to the prior dislodgements.Upon 80% deployment of the second valve, it was determined that the positioning was too high relative to the target implant depth of 0-1 millimeters (mm) on the non-coronary cusp (ncc) and above the annular plane on the left coronary cusp (lcc), it was determined necessary to recapture the valve.Upon the attempted recapture, the deployment knob was turned too quickly, resulting in inadvertent deployment of the valve.The valve ultimately dislodged to above the sinotubular junction (stj) on the ncc and 1-2 mm below the stj on the lcc, resulting in embolization.Subsequently, the valve was snared into the ascending aorta.A third valve was opened and used to complete the procedure.It was reported that a 90 minute procedural delay occurred as a result.Additional information was received that the deployment knob was turned in the wrong direction upon attempting to recapture which led to the inadvertent deployment.
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.

• 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: 23783103
• Report Number: 9612164-2025-06141
• Device Sequence Number: 10144694
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)260313(10)0012185675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/16/2026

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: 03/13/2026
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012185675
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/21/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/16/2026
• Date Device Manufactured: 03/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG