MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTPRO-26-US
Medical Device Problem Codes	Gradient Increase (1270); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849); Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453); Transvalvular Pressure Gradient Increased (4854)
Date of Event	10/10/2024
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 that seven years after the implant of the 26 mm evolut pro transcatheter aortic valve, the patient experienced exertional dyspnea and fatigue.Two months later, an echocardiogram revealed aortic stenosis, with a mean gradient of 35 mmhg, moderate mitral regurgitation, and moderate tricuspid regurgitation.No hospitalizations occurred due to these issues.It was also reported that the evolut pro appears to be implanted within a homograft or stentless xenograft surgical aortic valve, and a possible plaque /thrombus versus inadequate contrast filling was seen near the valve.It is unknown if any treatment/intervention was provided or is planned.
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 seven years after the implant of the 26 mm evolut pro transcatheter aortic valve, the patient experienced exertional dyspnea and fatigue.Two months later, an echocardiogram revealed aortic stenosis, with a mean gradient of 35 mmhg, moderate mitral regurgitation, and moderate tricuspid regurgitation.No hospitalizations occurred due to these issues.It was also reported that the evolut pro appears to be implanted within a homograft or stentless xenograft surgical aortic valve, and a possible plaque /thrombus versus inadequate contrast filling was seen near the valve.It is unknown if any treatment/intervention was provided or is planned.Additional information was received that the mean gradient before the valve was implanted was 27 mm.A transesophageal echocardiogram (tee) prior to the valve implant confirmed severe aortic stenosis.Following the valve implant, the mean gradient was 9 mmhg.Anti-platelet therapy of acetylsalicylic acid (asa) and plavix was prescribed.The valve gradient at discharge was 5.4 mmhg.No thrombus was present.The treatment plan is ongoing surveillance with clinical monitoring.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21552521
• Report Number: 2025587-2025-01759
• Device Sequence Number: 4643545
• Product Code: NPT
• UDI-Device Identifier: 00643169954441
• UDI-Public: 00643169954441
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 06/14/2019
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/11/2025
• Date Device Manufactured: 07/04/2017
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 83 KG