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	Activation Failure (3270); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Bradycardia (1751); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Swelling/ Edema (4577)
Date of Event	01/07/2026
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 that one day following a valve-in-valve procedure with the transcatheter aortic valve evfxplus-23 within an unspecified pre-existing valve, new atrial fibrillation with left bundle branch block was identified on electrocardiogram.Cardiac monitoring was performed using a zio patch.Approximately two weeks later, the patient presented with symptomatic bradycardia, with a heart rate in the 30s and systolic blood pressure in the 70s, resulting in hospitalization for evaluation and management.Treatment included unspecified intravenous medications.Subsequently, a permanent pacemaker was implanted three days after presentation.
Event or Problem Description
Additional information received indicated that the previous pre-existing heart valve was a non-medtronic valve.Approximately 2 weeks following the medtronic transcatheter valve implant dizziness, swelling, and difficulty in breathing developed associated with the symptomatic bradycardia and hospitalization.The primary indication for the permanent pacemaker was the left bundle branch block (lbbb) and atrial fibrillation.The patient was discharged 5 days following admission.The symptoms resolved at the time of discharge.
Additional Manufacturer Narrative
Updated data: b5, 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 received indicated the left bundle branch block (lbbb) and atrial fibrillation event resolved with sequelae.
Additional Manufacturer Narrative
Updated data: b5, 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.

• 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 ; +353 091708096
• MDR Report Key: 24189072
• Report Number: 9617601-2026-00633
• Device Sequence Number: 8131636
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2026

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?: No
• 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 05/12/2026; 08/18/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/24/2026; 06/03/2026; 09/14/2026
• Date Device Manufactured: 09/11/2025
• 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
• Patient Weight: 214 LB
• Patient Race: White