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-29-US
Medical Device Problem Codes	Gradient Increase (1270); Perivalvular Leak (1457); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Peripheral Edema (4578); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
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 following the implant of this 29mm transcatheter aortic bioprosthetic valve (tav), moderate paravalvular leak (pvl) was noted.No treatment was required.Approximately eight years, eleven and a half months following valve implant, valve failure was reported.The primary mode of valve failure was structural valve deterioration: predominant aortic stenosis with severe hemodynamic valve deterioration.This was characterized by an increase in mean gradient of >=20mm hg from baseline and a mean gradient of >=30mm hg.The patient was enrolled in a clinical study with existing, baseline valve failure to determine whether a redo-transcatheter aortic valve replacement procedure, tav-in-tav, was appropriate.No patient symptoms nor complications were reported as a result of this event.
Event or Problem Description
Additional information received indicated that baseline symptoms included lower extremity swelling, fatigue, and shortness of breath.A valve-in-valve procedure revision was planned but not yet performed or scheduled.
Additional Manufacturer Narrative
Updated data: b5, h6 corrected data: a2.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 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: 23992205
• Report Number: 9617601-2026-00119
• Device Sequence Number: 10522741
• Product Code: NPT
• UDI-Device Identifier: 00643169638006
• UDI-Public: (01)00643169638006(17)180801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Report Date (Section B): 02/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: EVOLUTR-29-US
• Device Catalogue Number: EVOLUTR-29-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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 08/31/2016
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 60 KG