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	Calcified (1077); Gradient Increase (1270); Malposition of Device (2616); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Chest Pain (1776); Dyspnea (1816); Dizziness (2194)
Date of Event	11/16/2017
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 8 years and 8 months following the implant of a transcatheter aortic valve, valve stenosis was identified.
Event or Problem Description
Additional information was received that the patient experienced shortness of breath as a result of the stenosis.Leaflet calcification was observed.It was reported that an intervention was required for the stenosis, and the patient was being evaluated for a valve-in-valve procedure.It was also noted that the valve was implanted deep at 10mm on the non-coronary cusp at the initial implant.
Additional Manufacturer Narrative
Updated data: a4.B1.B2.B5.H1.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 8 years and 8 months following the implant of a transcatheter aortic valve, valve stenosis was identified.Additional information was received that the patient experienced shortness of breath as a result of the stenosis.Leaflet calcification was observed.It was reported that an intervention was required for the stenosis, and the patient was being evaluated for a valve-in-valve procedure.It was also noted that the valve was implanted deep at 10mm on the non-coronary cusp at the initial implant.Additional information was received that after admission, an echocardiogram showed a mean gradient of 44 mmhg and peak gradient of 80 mmhg.The stenosis was noted to be severe and the patient experienced chest pain and dizziness.The patient was on plavix but the indication and start date were not known.
Additional Manufacturer Narrative
Updated: b2, b3, b5, b6, b7, 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
This is a system report.The section d.Information is for the primary device, which was in use with the following device(s) which cannot be excluded as potential contributing factors to the adverse event: brand name: enveor delivery catheter system (dcs); product id: enveor-us; lot: unknown; udi: unknown; manufactured date: unknown; use by date: unknown; implant date: n/a; fda site id: 9612164.Corrected: b3, b5, h6, h11.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 (b)(6) following the implant of a transcatheter aortic valve, valve stenosis was identified.Additional information was received that the patient experienced shortness of breath as a result of the stenosis.Leaflet calcification was observed.It was reported that an intervention was required for the stenosis, and the patient was being evaluated for a valve-in-valve procedure.It was also noted that the valve was implanted deep at 10mm on the non-coronary cusp at the initial implant.Additional information was received that after admission; an echocardiogram showed a mean gradient of 44 mmhg and peak gradient of 80 mmhg.The stenosis was noted to be severe and the patient experienced chest pain and dizziness.The patient was on plavix but the indication and start date were not known.The initial deep implant depth was not intended and was reported to be likely due to the delivery catheter system (dcs) technology at the time.

• 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: 24054075
• Report Number: 9617601-2026-00249
• Device Sequence Number: 13188491
• Product Code: NPT
• UDI-Device Identifier: 00643169638006
• UDI-Public: (01)00643169638006(17)180112
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 02/20/2026

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: 01/12/2018
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 01/12/2026; 01/23/2026; 02/20/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/09/2026; 02/20/2026; 02/20/2026
• Date Device Manufactured: 05/16/2017
• 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; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 80 KG