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	Perivalvular Leak (1457); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Hemodynamic instability (4868)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one year and 10 months following the implant of a transcatheter aortic valve, severe paravalvular leak (pvl) was identified as well as heart failure and hemodynamic instability.Subsequently, a non-medtronic (abbott) valvular plug was implanted to treat the paravalvular leak (pvl).Per the physician, the valve did cause or contribute to the patient's pvl.Per the physician, the patient's calcified anatomy contributed to the patient's pvl.
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.
Additional Manufacturer Narrative
Updated data: b2.B5.D6b.Explanted date is unknown.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
It was reported that one year and 10 months following the implant of a transcatheter aortic valve, severe paravalvular leak (pvl) was identified as well as heart failure and hemodynamic instability.Subsequently, a non-medtronic valvular plug was implanted to treat the paravalvular leak (pvl).Per the physician, the valve did cause or contribute to the patient's pvl.Per the physician, the patient's calcified anatomy contributed to the patient's pvl.Additional information was received that prior to the implant of this transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed using a 22 millimeter (mm) balloon due to calcification.During the implant of the non-medtronic vascular plug, the physician recognized a pleural effusion caused by the wire when trying to cross the defect.Therefore, a sternotomy was performed, the transcatheter valve was explanted and replaced with a surgical aortic valve (unknown manufacturer).The patient survived the surgery, however, their condition is unknown.
Additional Manufacturer Narrative
Updated data: b5, d6b, h6.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 wire used during the implant of the vascular plug was a non-medtronic guidewire.Per the physician, the non-medtronic guidewire was believed to be the cause of the effusion.

• 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: 24781732
• Report Number: 9617601-2026-02268
• Device Sequence Number: 12295721
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: (01)00763000370701(17)250926
• 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
• 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): 05/22/2026

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: 09/26/2025
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 05/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/22/2026
• Date Device Manufactured: 09/27/2023
• 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; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 82 KG