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

Model Number	EVOLUTFX-26
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Thickening of Material (4056); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Inflammation (1932); Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446); Hemodynamic instability (4868)
Date of Event	01/16/2026
Type of Reportable Event	Death
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 three years following the implant of this 26mm transcatheter aortic bioprosthetic valve (tav), the patient presented with signs of heart failure and hemodynamic instability.Upon assessment, high gradients were noted; however, gradient levels were not provided and recent previous gradient levels were not reported for comparison.Five days after presentation, the tav was noted to be severely stenosed.Two weeks later, prior to the scheduled tav replacement, a bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (basilica) technique was unsuccessfully attempted.Subsequently, the basilica and tav replacement procedure were aborted.Two days later, the patient was brought back for re-intervention for the failed tav; the basilica technique was successful and a non-medtronic (edwards sapien) tav was implanted within the failed medtronic tav.At an unknown point during the post-operative hospital stay, the patient died.The cause of death was not received; however, the physician indicated the death was related to the medtronic valve and systemic inflammation from excess procedural radiation.
Event or Problem Description
Additional information was received that the mean gradient when the patient presented with high gradients was 86 millimeters of mercury (mm hg), and there was evidence of leaflet thickening on the transcatheter valve, but no evidence of thrombus on the transcatheter valve.Prior to the tav-in-tav, the patient was in cardiogenic shock from the transcatheter valve.Per the physician, the cause of death was unknown; however, it was noted that the cause of death was not cardiac.The patient's underlying medical history contributed to the death.
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.
Additional Manufacturer Narrative
Corrected data: b2.Date of death updated.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 ; +353 091708096
• MDR Report Key: 24723066
• Report Number: 9617601-2026-02109
• Device Sequence Number: 10161310
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/13/2026

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: 08/18/2024
• Device Model Number: EVOLUTFX-26
• Device Catalogue Number: EVOLUTFX-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 06/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/20/2026; 07/13/2026
• Date Device Manufactured: 08/19/2022
• 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; Hospitalization; Death; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 205 LB