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 Codes	Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Migration (4003)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); Transvalvular Pressure Gradient Increased (4854)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the implantation of a transcatheter aortic valve, the patient had a mean aortic valve gradient of 42 millimeters of mercury (mm hg).After initial implant of the valve into the patient's native annulus, it was noted that the patient had a mean valvular gradient of 20 mm hg.An echocardiogram was then obtained 30 days following implant of the transcatheter aortic valve, which revealed a mean valvular gradient of 45 mm hg.Subsequently, the patient received intervention in the form of surgical aortic valve replacement.
Additional Manufacturer Narrative
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 implantation of a transcatheter aortic valve, the patient had a mean aortic valve gradient of 42 millimeters of mercury (mm hg).After initial implant of the valve into the patient's native annulus, it was noted that the patient had a mean valvular gradient of 20 mm hg.An echocardiogram was then obtained 30 days following implant of the transcatheter aortic valve, which revealed a mean valvular gradient of 45 mm hg.Subsequently, the patient received intervention in the form of surgical aortic valve replacement.Additional information was received that a transesophageal echocardiogram (tee) was performed that revealed moderate aortic regurgitation (ar), and the physician believes the valve may have migrated aortic.There was no evidence of thrombus on the valve, and there was no patient factors that could have contributed to the elevated gradient.Subsequently, the surgical aortic valve replacement was planned but not performed yet.
Additional Manufacturer Narrative
Updated data: b5.H6.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that prior to the implantation of a transcatheter aortic valve, the patient had a mean aortic valve gradient of 42 millimeters of mercury (mm hg).After initial implant of the valve into the patient's native annulus, it was noted that the patient had a mean valvular gradient of 20 mm hg.An echocardiogram was then obtained 30 days following implant of the transcatheter aortic valve, which revealed a mean valvular gradient of 45 mm hg.Subsequently, the patient received intervention in the form of surgical aortic valve replacement.Additional information was received that a transesophageal echocardiogram (tee) was performed that revealed moderate aortic regurgitation (ar), and the physician believes the valve may have migrated aortic.There was no evidence of thrombus on the valve, and there was no patient factors that could have contributed to the elevated gradient.Subsequently, the surgical aortic valve replacement was planned but not performed yet.Additional information was received that the moderate ar was paravalvular leak (pvl), and the transcatheter valve migrated after acc ess site closure.The surgical aortic valve replacement was performed, and the transcatheter valve was explanted.
Additional Manufacturer Narrative
Updated data: b2.B5.D6b.Explanted date is unknown.Year is confirmed valid.H6.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 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: 24345737
• Report Number: 9617601-2026-01228
• Device Sequence Number: 18624602
• Product Code: NPT
• UDI-Device Identifier: 00763000716127
• UDI-Public: (01)00763000716127(17)270710(20)01
• 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: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 04/09/2026

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 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: 02/13/2026
• Supplement Date Received by Manufacturer: 02/16/2026; 03/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/11/2026; 04/09/2026
• Date Device Manufactured: 07/10/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female