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

Model Number	EVOLUTFX-23
Medical Device Problem Codes	Gradient Increase (1270); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Codes	Valvular Stenosis (2697); Heart Failure/Congestive Heart Failure (4446); Transvalvular Pressure Gradient Increased (4854)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that approximately 1 year and 10 months following the implant of a transcatheter valve, the patient was hospitalized due to congestive heart failure (chf) with a mean gradient of 40  millimeters of mercury (mm hg).A computed tomography (ct) scan was performed that revealed the valve failed due to aortic stenosis.Subsequently, the patient was evaluated for a possible balloon aortic valvuloplasty (bav), or transcatheter aortic valve-in-transcatheter aortic valve replacement.
Event or Problem Description
Additional information was received that prior to the valve implant, the mean gradient was 42 millimeters of mercury (mmhg).The vale was implanted at an implant depth of 3.5 millimeter (mm) on the non-coronary cusp (ncc) and 4 mm on the left coronary cusp (lcc) into the native annulus.Following the valve implant, the mean gradient was 6 mmhg.Approximately 1 year and 9 months following the valve implant, the patient was hospitalized for congestive heart failure (chf) and high gradient.Diuretic medication was provided and was later discharged.Per the physician, the patient's small annulus (perimeter of 60.7mm, area 286.3mm^2) contributed to the elevated gradient.
Additional Manufacturer Narrative
Updated data: b3 b5 e4 additional codes.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 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: 23800011
• Report Number: 9617601-2025-03463
• Device Sequence Number: 7621678
• Product Code: NPT
• UDI-Device Identifier: 00763000370688
• UDI-Public: (01)00763000370688(17)250109
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/14/2026

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: 01/09/2025
• Device Model Number: EVOLUTFX-23
• Device Catalogue Number: EVOLUTFX-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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 01/10/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 67 KG