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

Model Number	EVOLUTFX-29
Medical Device Problem Codes	Fluid/Blood Leak (1250); Perivalvular Leak (1457)
Health Effect - Clinical Codes	Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 1 year and 9 months following the implant of a transcatheter aortic valve, aortic regurgitation was identified.
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 (b)(6) following the implant of a transcatheter aortic valve, aortic regurgitation was identified.Additional information was received that prior to the implant of this valve in a patient with sievers type 1 bicuspid aortic valve with right and left coronary cusp fusion, the patient had a pre-existing mean gradient of 32 millimeters of mercury (mm hg).A pre-implant balloon aortic valvuloplasty (bav) was performed using a 21 millimeter (mm) non-medtronic balloon.Following the implant of the valve, the post-procedural mean gradient was 3 mm hg with minimal paravalvular leak (pvl).Approximately 1 month following the implant of the valve, trace pvl was noted on an echocardiogram.Approximately 9 months following the implant of the valve, mild pvl was noted on echocardiogram.Approximately 1 year and 3 months following the implant of the valve, moderate pvl was noted on echocardiogram.Approximately 1 year and 5 months following the implant of the valve, a cardiac magnetic resonance imaging (mri) was performed that revealed moderate to severe aortic regurgitation.Approximately 1 year and 8 months following the implant of the valve, a computed tomography angiogram (cta) was performed that revealed paravalvular leak adjacent to severe focal annular/lvot calcium.The leak measures 5.1 mm in diameter.Subsequently, a transesophageal echocardiogram (tee) was scheduled.
Additional Manufacturer Narrative
Updated data: b1.B2.B3.B5.H1.The original information indicated the event was a reportable malfunction.Additional information indicates that a life threatening injury occurred.The event is now a reportable serious injury.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.
Event or Problem Description
Additional information was received that the moderate-severe aortic regurgitation observed during the mri was paravalvular leak (pvl).The patient was scheduled for a transesophageal echocardiogram (tee) at a later date to determine the treatment plan.
Additional Manufacturer Narrative
Updated data: 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 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: 24458971
• Report Number: 9617601-2026-01451
• Device Sequence Number: 10051973
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: (01)00763000370701(17)251015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/15/2026

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: 10/15/2025
• Device Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/03/2026; 03/24/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/22/2026; 04/15/2026
• Date Device Manufactured: 10/16/2023
• 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: Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 101 KG