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	Gradient Increase (1270); Perivalvular Leak (1457); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Valvular Insufficiency/ Regurgitation (4449); Insufficient Information (4580); Transvalvular Pressure Gradient Increased (4854)
Date of Event	08/01/2025
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.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 6 years and 9 months following the implant of a transcatheter valve, a computed tomography (ct) scan was performed which revealed the valve had failed due to an unknown reason.Subsequently, a redo-transcatheter aortic valve replacement (tavr) procedure was discussed.
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 6 years and 9 months following the implant of a transcatheter valve, a computed tomography (ct) scan was performed which revealed the valve had failed due to an unknown reason.Subsequently, a redo-transcatheter aortic valve replacement (tavr) procedure was discussed.Additional information was received that the transcatheter valve was implanted into an existing surgical valve.The valve gradient at discharge was 15 mmhg with no paravalvular leak (pvl).A follow-up echocardiogram one month post-implant showed a 24 mmhg gradient with trace pvl.The exact failure mode was unknown but there was not a current plan for reintervention.
Additional Manufacturer Narrative
Corrected: 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
It was reported that approximately 6 years and 9 months following the implant of a transcatheter valve, a computed tomography (ct) scan was performed which revealed the valve had failed due to an unknown reason.Subsequently, a redo-transcatheter aortic valve replacement (tavr) procedure was discussed.Additional information was received that the transcatheter valve was implanted into an existing non-medtronic (carpentier-edwards perimount magna) surgical valve.The valve gradient at discharge was 15 mmhg with no paravalvular leak (pvl).A follow-up echocardiogram one month post-implant showed a 24 mmhg gradient with trace pvl.The exact failure mode was unknown but there was not a current plan for reintervention.
Additional Manufacturer Narrative
Image review: report review: case report provided from (b)(6) 2025.Evolut is implanted inside an edwards perimount 2800 or magna 3000 sav.Native aortic valve appears to be a sievers 0 bicuspid with only two sinuses seen.Possible pannus/thrombus or thickened leaflets vs.Inadequate contrast filling seen inside tav frame.Evolut implant depth: left coronary cusp (lcc) ~12.8 mm and right coronary cusp (rcc) ~13.4 mm.Tortuosity noted in left common iliac.Transesophageal echocardiogram (tee) provided from (b)(6) 2025.Implant depth appears deep.Unable to clearly visualize prosthetic leaflets.Possible paravalvular leak (pvl) with moderate to severe aortic regurgitation.Mild mitral regurgitation.Atrio-ventricular (av) mean gradient is 8 mmhg, may be higher, the interrogation line does not appear parallel to flow.Updated h.6.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 indicating that seven years and two months following the valve implant, a non-medtronic transcatheter valve was implanted.The post-procedure gradient was 9 millimeters of mercury (mm hg).
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.

• 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: 22852574
• Report Number: 9617601-2025-01082
• Device Sequence Number: 17248067
• Product Code: NPT
• UDI-Device Identifier: 00763000017675
• UDI-Public: (01)00763000017675(17)200723
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup,Followup
• Report Date (Section B): 12/16/2025

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: 07/23/2020
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/19/2025; 10/21/2025; 12/03/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/19/2025; 10/15/2025; 10/22/2025; 12/16/2025
• Date Device Manufactured: 08/09/2018
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 115 KG