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

Model Number	EVOLUTR-26-US
Medical Device Problem Codes	Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Dyspnea (1816); Cusp Tear (2656); Valvular Insufficiency/ Regurgitation (4449); Swelling/ Edema (4577)
Date of Event	09/09/2025
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 approximately 6 years and 6 months following the implant of a 26 millimeter (mm) transcatheter valve in a previously implanted 25 mm non-medtronic surgical aortic valve, the patient was admitted to the hospital due to increased dyspnea, and fluid retention.A transthoracic echocardiogram (tte) was performed that revealed severe central aortic regurgitation, decreased left ventricular ejection fraction (ef), and enlarged inferior vena cava with no respiratory collapse.A transesophageal echocardiogram (tee) was performed that revealed the mechanism of aortic regurgitation to be cusp degeneration with leaflet retraction and likely leaflet tear.Additionally, mild anterior paravalvular leak (pvl) was observed and there was no evidence of endocarditis.An electrocardiogram (ecg) was also performed that revealed new atrial fibrillation (afib).Four days following the tte, tee and ecg, a positron emission tomography (pet) scan with computed tomography (ct) scan was performed that revealed no convincing findings for infective endocarditis.Subsequently, the patient was administered subcutaneous (sq) heparin, and a transcatheter aortic valve replacement procedure was planned.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC 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: 23391721
• Report Number: 9617601-2025-02234
• Device Sequence Number: 9844582
• Product Code: NPT
• UDI-Device Identifier: 00763000017668
• UDI-Public: (01)00763000017668(17)200826
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: 08/26/2020
• Device Model Number: EVOLUTR-26-US
• Device Catalogue Number: EVOLUTR-26-US
• 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: 09/30/2025
• Initial Report FDA Received Date: 10/27/2025
• Date Device Manufactured: 09/13/2018
• 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; Life Threatening
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 81 KG