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	Calcified (1077); Gradient Increase (1270); Patient Device Interaction Problem (4001); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Valvular Stenosis (2697); Cardiovascular Dysfunction/Insufficiency (4445); Aortic Valve Insufficiency/ Regurgitation (4450); Transvalvular Pressure Gradient Increased (4854)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 7 years and 9 months following the implant of a transcatheter aortic valve, the patient had the onset of atrial fibrillation with rapid ventricular response.Subsequently, the patient was hospitalized.During this hospitalization, an echocardiogram was obtained which revealed a reduced ejection fraction of 30-35%, a mean valvular gradient of 28 millimeters of mercury (mm hg), moderate aortic stenosis, and mild central regurgitation.
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
Additional information was received that a non-medtronic valve was implanted valve-in-valve.
Additional Manufacturer Narrative
Updated data: b5.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
Image review: a case report and one 3mensio video clip provided from imaging services, dated (b)(6) 2026 showed mild calcification of prosthetic leaflets.The evolut implant appears under-expanded at the inflow, node 1, and node 2.Calcification is observed outside the transcatheter aortic valve (tav) frame near the left coronary cusp (lcc) and non-coronary cusp (ncc).Implant depth measures 7.1 mm beneath the lcc and right coronary cusp (rcc), and 2.7 mm beneath the ncc.Within the tav frame, there is a possible pannus or thrombus, although inadequate contrast filling cannot be excluded.Similarly, possible plaque or thrombus versus inadequate contrast filling is noted in the ncc, and a potential left atrial appendage (laa) thrombus versus inadequate contrast filling is also observed.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.
Event or Problem Description
Additional information was received that the valve was implanted at a depth of approximately 7.1 mm on the left coronary cusp and 2.7 mm on the non-coronary cusp.The leaflets appeared calcified via computed tomography.Subsequently, the patient was scheduled to have a non-medtronic valve implanted valve-in-valve as treatment.

• 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: 24177906
• Report Number: 9617601-2026-00563
• Device Sequence Number: 18531103
• Product Code: NPT
• UDI-Device Identifier: 00643169637993
• UDI-Public: (01)00643169637993(17)191228
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2019
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 01/26/2026; 02/21/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/20/2026; 02/23/2026
• Date Device Manufactured: 01/16/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 79 KG