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-29-US
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068); Unspecified Valve Regurgitation (4080)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Hemodynamic instability (4868)
Date of Event	03/10/2026
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 8 years and 5 months following the implant of a transcatheter aortic valve, an unspecified valve failure occurred.Subsequently, the patient experienced heart failure and hemodynamic instability.
Event or Problem Description
Additional information was received that the valve failed due to severe aortic regurgitation, which was identified in recent echocardiogram reports.It was planned to treat the failed valve with a non-medtronic transcatheter valve.
Additional Manufacturer Narrative
Image review: one 3mensio video clip was provided, displaying scrolling computed tomography (ct) imaging of the aortic valve from below the evolut inflow to outflow.The implant appears to be at the targeted depth.Protruding calcification is observed inside the left ventricular outflow tract (lvot) under the non-coronary cusp (ncc).Calcification under the left coronary cusp (lcc) appears to extend to the mitral annular calcification (mac).Additional calcification is seen outside the transcatheter aortic valve (tav) frame within the native cusps, and protruding calcification is noted inside the tav frame near the lcc at the level of the coronary.The evolut valve appears under-expanded.Updated data: b1, b2, b5, h1, h6.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: 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
It was reported that 8 years and 5 months following the implant of a transcatheter aortic valve, an unspecified valve failure occurred.Subsequently, the patient experienced heart failure and hemodynamic instability.Additional information was received that the valve failed due to severe aortic regurgitation, which was identified in recent echocardiogram reports.It was planned to treat the failed valve with a non-medtronic transcatheter valve.Additional information was received that the severe aortic regurgitation was central regurgitation.

• 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: 24594087
• Report Number: 9617601-2026-01813
• Device Sequence Number: 18730925
• Product Code: NPT
• UDI-Device Identifier: 00643169954458
• UDI-Public: (01)00643169954458(17)190711
• 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: 2017
• 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): 04/24/2026

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: 07/11/2019
• Device Model Number: EVOLUTPRO-29-US
• Device Catalogue Number: EVOLUTPRO-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: 03/10/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/01/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/24/2026
• Date Device Manufactured: 07/19/2017
• 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; Life Threatening
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 22 KG