MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-34
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); High Blood Pressure/ Hypertension (1908); Peripheral Edema (4578)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 4 days following the implant of this transcatheter bioprosthetic aortic valve within a pre-existing medtronic transcatheter valve, the patient presented to the emergency department with non-cardiac chest pain and a hypertensive emergency.The systolic blood pressure measured in the range of 210  millimeters of mercury (mm hg) and the diastolic blood pressure was >100 mmhg.The chest pain was a short lived episode of midsternal, non-radiating chest pressure, shortness of breath, dyspnea on exertion, and mild low extremity swelling.An electrocardiogram (ecg) showed no evidence of obvious st elevations to indicate acute ischemia or infarct.Troponins were reported as ¿flat¿ which measured 45 and 41.The b-type natriuretic peptide (bnp) was minimally elevated at 149.Intravenous diuretics and a nitroglycerin drip were administered.Cardiology was consulted.Hospitalization was required and was prolonged by the hypertensive event.Discharge occurred 2 days following admission.The chest pain event was reported causal related to the transcatheter valve.The hypertensive event was reported as unrelated to the medtronic products and the implant procedure.The cause was not reported.Both events were reported as resolving.
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.

• 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(091)708096
• MDR Report Key: 50069191
• Report Number: 9617601-2026-04689
• Device Sequence Number: 16006771
• Product Code: NPT
• UDI-Device Identifier: 00763000716158
• UDI-Public: (01)00763000716158(17)280217(20)01
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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-34
• Device Catalogue Number: EVFXPLUS-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 02/17/2026
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 258 LB
• Patient Race: White