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-34-US
Medical Device Problem Codes	Calcified (1077); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Non specific EKG/ECG Changes (1817); Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446); Unspecified Kidney or Urinary Problem (4503)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from the patient that approximately 7 years and 11 months following the implant of a transcatheter valve, the patient experienced symptoms of dyspnea and pleural effusion.Additionally, the patient noted having a permanent pacemaker an unspecified amount of time following the implant of the transcatheter valve, ejection fraction of 35%-40%, congestive heart failure (chf), kidney problems, and was evaluated for these conditions.
Additional Manufacturer Narrative
B3.Event date is not known.Please see b5 for approximate date range.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 from the patient that approximately seven years and eleven months following the implant of a transcatheter valve, the patient experienced symptoms of dyspnea and pleural effusion.Additionally, the patient noted having a permanent pacemaker an unspecified amount of time following the implant of the transcatheter valve, ejection fraction of 35%-40%, congestive heart failure (chf), kidney problems, and was evaluated for these conditions.Additional information was received indicating that no conduction disturbance was noted, but the patient had a cardiac resynchronization therapy defibrillator (crt-d) implanted approximately three years and nine months after the transcatheter valve implant.It was also confirmed that the transcatheter valve did not fail.
Additional Manufacturer Narrative
Additional information: b5 (second paragraph).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
Updated 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.
Event or Problem Description
Additional information was received that approximately (b)(6) after valve implant, stenosis and valve calcification were identified.Subsequently, a redo transcatheter aortic valve replacement was planned.
Additional Manufacturer Narrative
Updated data: b5.E2.E3.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.

• 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: 23556008
• Report Number: 9617601-2025-02746
• Device Sequence Number: 10160340
• Product Code: NPT
• UDI-Device Identifier: 00643169792340
• UDI-Public: (01)00643169792340(17)190725
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2026

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 Expiration Date: 07/25/2019
• Device Model Number: EVOLUTR-34-US
• Device Catalogue Number: EVOLUTR-34-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: 10/22/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 12/29/2025; 03/13/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/23/2026; 04/03/2026
• Date Device Manufactured: 08/08/2017
• 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
• Patient Age: 76 YR
• Patient Sex: Male