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); Patient Device Interaction Problem (4001); Thickening of Material (4056); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Muscle Weakness/Atrophy (1967); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/10/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that approximately 2 months following the implant of a transcatheter valve in the patient's native annulus, an echocardiogram was performed that revealed moderate to severe aortic valve stenosis, and a mean gradient of 33 millimeters of mercury (mm hg) with a valve area of 0.7 square centimeters.It was noted that the implant depth at the non-coronary cusp (ncc) was 8 millimeters (mm), and the implant depth at the left coronary cusp (lcc) was 8 mm.Approximately 1 year following the implant of the transcatheter valve, the patient presented with weakness and dyspnea.It was reported that the patient had elevated troponin levels and elevated n-terminal pro-b-type natriuretic peptide (nt-probnp) levels.Subsequently, a computed tomography angiogram (cta) scan was performed that showed bilateral pulmonary emboli involving the right segmental and subsegmental branches, as well as in the distal left main pulmonary artery extending into the segmental left upper lobe branches.Additionally, significant peripheral hypoattenuated leaflet thickening (halt) on the valve leaflets and reduced systolic excursion were observed.Following the cta, an echocardiogram was performed that showed moderate central aortic regurgitation, a mean gradient of 51 mm hg, and a peak velocity of 4.99 meters per second.Following the echocardiogram, a computed tomography (ct) scan was performed that revealed thrombus/pannus formation on the valve leaflets, and a 73 degree aortic root angle.It was reported that continued monitoring was recommended as the patient has been asymptomatic.Per the physician, the transcatheter valve contributed to the patient's symptoms.
Additional Manufacturer Narrative
Updated data: b3.Date of event b5.A second paragraph was added.H6.Thrombus codes were removed.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 approximately 2 months following the implant of a transcatheter valve in the patient's native annulus, an echocardiogram was performed that revealed moderate-severe aortic valve stenosis, and a mean gradient of 33 millimeters of mercury (mm hg) with a valve area of 0.7 square centimeters.It was noted that the implant depth at the non-coronary cusp (ncc) was 8 millimeters (mm), and the implant depth at the left coronary cusp (lcc) was 8 mm.Approximately 1 year following the implant of the transcatheter valve, the patient presented with weakness and dyspnea.It was reported that the patient had elevated troponin levels and elevated n-terminal pro-b-type natriuretic peptide (nt-probnp) levels.Subsequently, a computed tomography angiogram (cta) scan was performed that showed bilateral pulmonary emboli involving the right segmental and subsegmental branches, as well as in the distal left main pulmonary artery extending into the segmental left upper lobe branches.Additionally, significant peripheral hypoattenuated leaflet thickening (halt) on the valve leaflets and reduced systolic excursion were observed.Following the cta, an echocardiogram was performed that showed moderate central aortic regurgitation, a mean gradient of 51 mm hg, and a peak velocity of 4.99 meters per second.Following the echocardiogram, a computed tomography (ct) scan was performed that revealed thrombus/pannus formation on the valve leaflets, and a 73 degree aortic root angle.It was reported that continued monitoring was recommended as the patient has been asymptomatic.Per the physician, the transcatheter valve contributed to the patient's symptoms.Additional information was received to correct previously documented information: "according to op note reassessment by echo revealed an excellent depth of implant at approximately 2 mm beneath the non and left coronary sinus." there was no mention of and no echocardiogram performed showing thrombus.The halt was observed on cta approximately four years following the valve implant.The patient was taking a nonsteroidal anti-inflammatory drug (nsaid) and an antiplatelet agent medication following initial valve implant.After the cta showed halt, the patient was started on a heparin drip, then discharged on a direct oral anticoagulant and the previously prescribed nsaid medication.

• 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: 21919996
• Report Number: 2025587-2025-03067
• Device Sequence Number: 21090405
• Product Code: NPT
• UDI-Device Identifier: 00763000211103
• UDI-Public: 00763000211103
• 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: 2021
• 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): 05/27/2025

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: 10/23/2022
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/27/2025
• Date Device Manufactured: 10/23/2020
• 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: Life Threatening
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 58 KG