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

Model Number	EVOLUTPRO-26-US
Medical Device Problem Codes	Gradient Increase (1270); Perivalvular Leak (1457); Insufficient Device Problem Information (3190); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450); Swelling/ Edema (4577); Transvalvular Pressure Gradient Increased (4854)
Date of Event	09/01/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported, approximately six years, eleven-and-a-half months following the implant of this transcatheter aortic bioprosthetic valve (tav), tav failure was noted and further characterized as stenosis.The patient was hospitalized.No further information was reported as a result of this event.
Additional Manufacturer Narrative
B3: the onset date of the stenosis was not provided, the date of medtronic awareness was used as a reasonable event date.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: b2.B3.B3: date is approximate.Year is confirmed valid.B5.H1.The original information indicated the event was a serious injury.Additional information indicates that the patient died.The event is now a reportable death.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 approximately 6 years and 5 months following the implant of this tav, the patient became symptomatic with multifactorial dyspnea, lower extremity swelling, and orthopnea.Approximately 5 months later, the patient was hospitalized.Approximately one month following admission, the patient was discharged from the hospital.However, three days following discharge, the patient was re-admitted and transferred to a different hospital for a second surgical opinion.A transesophageal echocardiogram (tee) was performed that revealed the severe stenosis with a mean gradient of 56 millimeters of mercury (mm hg), severe central aortic regurgitation, as well as severe paravalvular leak (pvl), and the patient was denied structural and surgical intervention.Approximately 3 weeks after re-admission, the patient was discharged home with hospice care.Three days later, the patient died.
Event or Problem Description
Additional information was received that the patient was denied intervention from both hospitals due to her health.The patient died in hospice.
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.

• Brand Name: EVOLUT PRO 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: 24723569
• Report Number: 9617601-2026-02107
• Device Sequence Number: 10331341
• Product Code: NPT
• UDI-Device Identifier: 00763000017828
• UDI-Public: (01)00763000017828(17)200708
• 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: 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,Followup,Followup
• Report Date (Section B): 05/21/2026

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: 07/08/2020
• Device Model Number: EVOLUTPRO-26-US
• Device Catalogue Number: EVOLUTPRO-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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 05/19/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/19/2026; 05/21/2026
• Date Device Manufactured: 07/26/2018
• 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; Life Threatening; Death
• Patient Age: 67 YR
• Patient Sex: Female