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

Model Number	EVPROPLUS-23US
Medical Device Problem Codes	Gradient Increase (1270); Device Stenosis (4066)
Health Effect - Clinical Codes	Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
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
Medtronic received information that during the implant of this transcatheter bioprosthetic valve into a previously implanted non-medtronic surgical valve, fluoroscopy and transthoracic echocardiogram (tte) showed good positioning at 80% deployed.Upon full release of the valve, the valve dislodged to the ascending aorta.The implanting team believed there was back tension on the delivery catheter system (dcs) that snagged the valve although forward pressure was applied upon the valve release.A snare was used on a paddle of the first valve and a second valve was implanted successfully.Post valve implant angiogram confirmed coronary perfusion and greater head vessels.No additional adverse patient effects were reported.  additional information was received that approximately 4 years following the initial valve implant procedure, the cardiologist noted a systolic murmur.An echocardiogram was performed that revealed the valve appeared well seated.The gradient at the time was borderline with a peak velocity of 2.4 m/s.A transesophageal echocardiogram (tee) was later performed which revealed flow acceleration between the 2 transcatheter valves and an elevated gradient of 15-17 millimeters of mercury (mm hg).A computed tomography (ct) angiogram was also performed that revealed there was no evidence of leaflet thrombosis, and the valve that had previously dislodged during the initial implant procedure, was observed in the ascending aortic arch.Subsequently, the valve that was implanted in the annulus was reported to had failed due to moderate aortic stenosis.The patient was being evaluated for a valve-in-valve or surgical procedure.
Additional Manufacturer Narrative
Updated data: b5.D4.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 the mean gradient before the valve was implanted was 25 mm hg.The mean gradient after the valve was implanted was 9 mmhg.The depth of implant of the valve was 3-4 mm below the previously implanted bioprosthetic valve.

• Brand Name: EVOLUT PRO PLUS 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: 22337698
• Report Number: 2025587-2025-04551
• Device Sequence Number: 8930448
• Product Code: NPT
• UDI-Device Identifier: 00763000211103
• UDI-Public: (01)00763000211103(17)220302(21)D348386
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 07/25/2025

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: 03/02/2022
• Device Model Number: EVPROPLUS-23US
• Device Catalogue Number: EVPROPLUS-23US
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 03/19/2020
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 66 KG