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

Model Number	EVOLUTFX-34
Medical Device Problem Codes	Fluid/Blood Leak (1250); Perivalvular Leak (1457); Activation Failure (3270); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
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 approximately one year and nine-and-a-half months following implant of this 34mm transcatheter aortic bioprosthetic valve, significant unspecified aortic regurgitation was reported.A proctor review of the diagnostic imaging was performed and noted the implant depth of the valve frame ranged between 6.8 - 7.5mm to the native annulus and the valve frame appeared to be under-expanded.The proctor noted the computed tomography angiogram was not of great quality and had grainy images; therefore, was difficult to determine whether the valve frame was approximated against the annular tissue or not.The proctor recommended valve replacement with a balloon-expandable valve.No treatment was reported at this time.No other patient complications were reported due to this event.
Additional Manufacturer Narrative
Updated data: a4.Weight in lbs.B1.Adverse event and product problem.B2.Outcome attributed to adverse event.B3.Date of event.B5.A second paragraph was added.H1.The original information indicated the event was a reportable malfunction.Additional information indicates that intervention was required.The event is now a reportable serious injury.H6.Annex a codes.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.
Event or Problem Description
It was reported approximately one year and nine months following implant of this 34 mm transcatheter aortic bioprosthetic valve, significant unspecified aortic regurgitation was reported.A proctor review of the diagnostic imaging was performed and noted the implant depth of the valve frame ranged between 6.8 - 7.5mm to the native annulus and the valve frame appeared to be under-expanded.The proctor noted the computed tomography angiogram was not of great quality and had grainy images; therefore, was difficult to determine whether the valve frame was approximated against the annular tissue or not.The proctor recommended valve replacement with a balloon-expandable valve.No treatment was reported at this time.No other patient complications were reported due to this event.Additional information was received to report the severity of the aortic regurgitation was moderate-severe, and both central aortic regurgitation and paravalvular leak (pvl) were observed.It was noted that the patient was asymptomatic.Subsequently, it was planned for a vascular plug to be implanted for pvl closure.Per the physician, the depth of implant of the valve contributed to the event.
Event or Problem Description
It was reported approximately one year and nine months following implant of this 34 mm transcatheter aortic bioprosthetic valve, significant unspecified aortic regurgitation was reported.A proctor review of the diagnostic imaging was performed and noted the implant depth of the valve frame ranged between 6.8 - 7.5mm to the native annulus and the valve frame appeared to be under-expanded.The proctor noted the computed tomography angiogram was not of great quality and had grainy images; therefore, was difficult to determine whether the valve frame was approximated against the annular tissue or not.The proctor recommended valve replacement with a balloon-expandable valve.No treatment was reported at this time.No other patient complications were reported due to this event.Additional information was received to report the severity of the aortic regurgitation was moderate-severe, and both central aortic regurgitation and paravalvular leak (pvl) were observed.It was noted that the patient was asymptomatic.Subsequently, it was planned for a vascular plug to be implanted for pvl closure.Per the physician, the depth of implant of the valve contributed to the event.Additional information was received that the echocardiogram showed pvl; however, the regurgitation appeared to be central due to the imaging.Therefore, it was hard to determine if the regurgitation was central regurgitation versus pvl.Regardless of this, the severity of both the central aortic regurgitation and pvl was moderate-severe.Approximately one year and 10 months following the implant of this valve, the pvl closure with a vascular plug was performed as treatment.
Additional Manufacturer Narrative
Updated data: b2.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.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: 24327250
• Report Number: 9617601-2026-01176
• Device Sequence Number: 9542132
• Product Code: NPT
• UDI-Device Identifier: 00763000370718
• UDI-Public: (01)00763000370718(17)260209
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 03/20/2026

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: 02/09/2026
• Device Model Number: EVOLUTFX-34
• Device Catalogue Number: EVOLUTFX-34
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 02/05/2026; 03/03/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 133 KG