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

Model Number	EVPROPLUS-23US
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Thickening of Material (4056)
Health Effect - Clinical Codes	Endocarditis (1834); Foreign Body Reaction (1868); Pneumonia (2011); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/02/2022
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 1 year and 2 months following the implant of a transcatheter valve, endocarditis was confirmed and the organism cultured was streptococci.It was noted that the patient had active pneumonia which could have predisposed the patient to endocarditis.Additionally, vegetation was not present on echocardiogram.The patient is currently prescribed suppressive antib iotics.Per the physician, the valve and implant procedure did not cause or contribute to the infection.Approximately 4 years and 2 months following the implant of the valve, a computed tomography (ct) scan was performed that revealed the valve failed due to an unknown reason and the patient was hospitalized.Additionally, possible thrombus/pannus was observed inside the valve frame.
Event or Problem Description
It was reported that approximately 1 year and 2 months following the implant of a transcatheter valve, endocarditis was confirmed and the organism cultured was streptococci.It was noted that the patient had active pneumonia which could have predisposed the patient to endocarditis.Additionally, vegetation was not present on echocardiogram.The patient is currently prescribed suppressive antibiotics.Per the physician, the valve and implant procedure did not cause or contribute to the infection.Approximately 4 years and 2 months following the implant of the valve, a computed tomography (ct) scan was performed that revealed the valve failed due to an unknown reason and the patient was hospitalized.Additionally, possible thrombus/pannus was observed inside the valve frame.Additional information was received that the transcatheter valve was implanted into the native annulus at a final depth of 4.9 mm on the left coronary cusp (lcc).The valve failure was due to endocarditis leading to leaflet thickening.Thrombus/pannus was confirmed with thrombus noted on the valve leaflets.The patient died before receiving treatment to address the failed valve.The patient had a history of endocarditis.
Additional Manufacturer Narrative
Updated: 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: 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
It was reported that approximately 1 year and 2 months following the implant of a transcatheter valve, endocarditis was confirmed and the organism cultured was streptococci.It was noted that the patient had active pneumonia which could have predisposed the patient to endocarditis.Additionally, vegetation was not present on echocardiogram.The patient is currently prescribed suppressive antibiotics.Per the physician, the valve and implant procedure did not cause or contribute to the infection.Approximately 4 years and 2 months following the implant of the valve, a computed tomography (ct) scan was performed that revealed the valve failed due to an unknown reason and the patient was hospitalized.Additionally, possible thrombus/pannus was observed inside the valve frame.Additional information was received that the transcatheter valve was implanted into the native annulus at a final depth of 4.9 mm on the left coronary cusp (lcc).The valve failure was due to endocarditis leading to leaflet thickening.Thrombus/pannus was confirmed with thrombus noted on the valve leaflets.The patient died before receiving treatment to address the failed valve.The patient had a history of endocarditis.Additional information was received that per the physician, the official cause of death was heart failure exacerbation and the valve was a contributing factor.

• 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: 23810987
• Report Number: 9617601-2025-03493
• Device Sequence Number: 20754542
• Product Code: NPT
• UDI-Device Identifier: 00763000211103
• UDI-Public: (01)00763000211103(17)230623
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 02/23/2026

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: 06/23/2023
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/27/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/14/2026; 02/23/2026
• Date Device Manufactured: 06/23/2021
• 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; Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 79 KG