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

Model Number	EVPROPLUS-34US
Medical Device Problem Codes	Calcified (1077); Perivalvular Leak (1457); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Fever (1858); Hemoptysis (1887); Unspecified Infection (1930); Myocardial Infarction (1969); Pulmonary Edema (2020); Cardiogenic Shock (2262); Prolapse (2475); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Hemodynamic instability (4868)
Date of Event	05/06/2020
Type of Reportable Event	Death
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 approximately 5 years and 10 months following the implant of a transcatheter aortic valve, the valve failed due to severe central aortic regurgitation and severe aortic stenosis.The patient suffered from hemodynamic instability, and was re-hospitalized as a result.
Additional Manufacturer Narrative
Updated data: b2, b3, b5, e1, 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
It was reported that approximately 5 years and 10 months following the implant of a transcatheter aortic valve, the valve failed due to severe central aortic regurgitation and severe aortic stenosis.The patient suffered from hemodynamic instability, and was re-hospitalized as a result.Additional information was received that this 34 millimeter (mm) transcatheter aortic valve (tav) was implanted in a previously implanted 27 mm medtronic surgical aortic valve (sav).The post-implant mean gradient was 2 millimeters of mercury (mm hg), and moderate paravalvular leak (pvl) was observed.Therefore, a post-implant balloon aortic valvuloplasty (bav) was performed with a 26 mm non-medtronic balloon.Following the post-implant bav, no appreciable pvl was noted, and the final implant depth was 2-3 mm beneath the coronary sinuses.Approximately 5 years and 7 months following the implant of this tav, an echocardiogram was performed that showed the tav was well-seated with trace regurgitation, and normal valve function with a mean gradient of 5 mm hg and peak velocity of 1.5 meters per second (m/s).Three months later, the patient was admitted to the hospital with a non-st-elevation myocardial infarction (nstemi), cardiogenic shock, and acute pulmonary edema.One day following hospitalization, the patient required intubation and cardiac catheterization was performed that revealed severe native coronary artery disease with patent 2 grafts unchanged from before.On the same day, an echocardiogram was performed that revealed severe aortic regurgitation and no evidence of aortic valve stenosis.One day later, a transesophageal echocardiogram (tee) was performed that revealed severe aortic valve regurgitation with eccentrically directed jet.A computed tomography angiogram (cta) of the tav revealed severely calcified leaflets, and prolapse of the noncorona ry leaflet into the left ventricular outflow tract (lvot).Subsequently, it was planned to perform a redo tav in tav in sav as treatment.Additionally, the patient experienced fevers of unknown source and was placed on antibiotics as pneumonia was suspected.However, the patient's blood and sputum cultures were negative.Approximately one week later, the patient developed hemoptysis and heparin was held.A do not resuscitate (dnr) order was placed by the patient's family with comfort measures only, and the patient died one day later.
Additional Manufacturer Narrative
Updated data: b5.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.
Event or Problem Description
Additional information was received that neither pneumonia nor the source of the fevers were confirmed.The cardiac catheterization that was performed was diagnostic and revealed that the coronary arteries were all adequately perfusing.Per the physician, the troponin elevation may have been related to the severe aortic valve insufficiency and pulmonary edema.Additionally per the physician, the cause of death was congestive heart failure (chf) due to acute severe bioprosthetic aortic valve regurgitation.It was noted that the patient had a medical history of an aortic valve replacement and coronary artery bypass graft, and acute on chronic systolic and diastolic chf with an ejection fraction of 30%.

• Brand Name: EVOLUT PRO PLUS 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: 24778575
• Report Number: 9617601-2026-02253
• Device Sequence Number: 10036474
• Product Code: NPT
• UDI-Device Identifier: 00763000211158
• UDI-Public: (01)00763000211158(17)220105
• 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,Followup
• Report Date (Section B): 06/05/2026

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: 01/05/2022
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: EVPROPLUS-34US
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 05/12/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/05/2026; 06/05/2026
• Date Device Manufactured: 01/22/2020
• 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: Hospitalization; Life Threatening; Required Intervention; Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 90 KG