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

Model Number	EVOLUTR-29-US
Medical Device Problem Codes	Perivalvular Leak (1457); Intravalvular regurgitation (4068); Unspecified Valve Regurgitation (4080)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that immediately following initial implant of a transcatheter aortic valve into a previously implanted surgical valve, trace aortic valve paravalvular leak (pvl) was noted.7 years and 7 months following the implant of the transcatheter aortic valve, moderate aortic valve regurgitation was identified as well as severe mitral valve regurgitation via computed tomography (ct).
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 immediately following initial implant of a transcatheter aortic valve into a previously implanted surgical valve, trace aortic valve paravalvular leak (pvl) was noted.7 years and 7 months following the implant of the transcatheter aortic valve, moderate aortic valve regurgitation was identified as well as severe mitral valve regurgitation via computed tomography (ct) scan.Additional information was received to clarify that the moderate aortic regurgitation was central regurgitation.The moderate central aortic regurgitation and severe mitral valve regurgitation were identified via echocardiogram.Per the physician, the transcatheter aortic valve did not cause or contribute to the severe mitral regurgitation.
Additional Manufacturer Narrative
Updated data: b5.Corrected data: b3.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 data: b5.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 there was no plan to treat the patient's valve, and the patient will be monitored.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC 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: 24852051
• Report Number: 9617601-2026-02397
• Device Sequence Number: 12168339
• Product Code: NPT
• UDI-Device Identifier: 00763000017675
• UDI-Public: (01)00763000017675(17)200305
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/29/2026

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: 03/05/2020
• Device Model Number: EVOLUTR-29-US
• Device Catalogue Number: EVOLUTR-29-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: 04/07/2026
• Supplement Date Received by Manufacturer: 04/10/2026; 05/08/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/01/2026; 05/29/2026
• Date Device Manufactured: 03/22/2018
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG