MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-23
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the attempted implant of a transcatheter aortic valve, the valve dislodged between 0 millimeters (mm) and -1 mm on the non-coronary cusp (ncc) from the target implant depth of 3 mm.Subsequently, the valve was recaptured.Two additional redeployments and recaptures were made, with the valve dislodging to the same location on the ncc.On the 4th deployment attempt, the valve was positioned at 1 mm on the ncc and 3 mm on the left coronary cusp (lcc).A mean gradient of 40 millimeters of mercury (mm hg) was observed, and a post-implant balloon aortic valvuloplasty (bav) was performed with a 21 mm non-medtronic (becton dickson true) balloon.Subsequently, the valve embolized to the aorta.2 snares were utilized to reposition the valve above the sinotubular junction (stj).Another valve was opened and used to place the valve at 5 mm on the ncc and 8 mm on the lcc.Another post-implant bav was performed with a 22 mm non-medtronic (becton dickson true) balloon.A 1 hour procedural delay occurred as a result.Additional information was received that the first post-implant bav was performed due to frame under-expansion, and a mean gradient of 40 mm hg.Additionally, it was reported that the patient had a previously implanted 19 millimeter (mm) non-medtronic (trifecta) surgical aortic valve that contributed to the dislodge and high gradient.It was noted that a non-medtronic (safari) guidewire was used during the procedure.Additional information was received to report the post-implant bav was performed on the second valve because the valve frame was under-expanded.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: d-evolutfx-2329, serial/lot #: (b)(6), ubd: 29-aug-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.

• Brand Name: EVOLUT FX PLUS VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24003680
• Report Number: 9617601-2026-00150
• Device Sequence Number: 21463314
• Product Code: NPT
• UDI-Device Identifier: 00763000716127
• UDI-Public: (01)00763000716127(17)270714(20)01
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: EVFXPLUS-23
• Device Catalogue Number: EVFXPLUS-23
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/08/2026
• Date Device Manufactured: 07/14/2025
• 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...."
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 81 KG