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-34-US
Medical Device Problem Codes	Fluid/Blood Leak (1250); Unspecified Valve Regurgitation (4080)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, approximately seven years, ten months following the implant of this transcatheter aortic bioprosthetic valve (tav), the primary mode of tav failure was aortic regurgitation of an unknown severity and type.Subsequently, the patient was evaluated for possible re-intervention for the failed tav with a non-medtronic (edwards) tav.Upon review of tav evaluation images, the tav frame appeared elliptical/oval shaped.There was calcification present in the sinotubular junction which had a mean diameter of <(><<)>24mm.Of note, images revealed a possible native bicuspid valve.No patient symptoms were reported as a result of this event.
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.
Additional Manufacturer Narrative
Updated data: b1.B2.B5.H1.The original information indicated the event was a reportable malfunction.Additional information indicates that intervention was required.The event is now a reportable serious injury.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, approximately seven years, ten months following the implant of this transcatheter aortic bioprosthetic valve (tav), the primary mode of tav failure was aortic regurgitation of an unknown severity and type.Subsequently, the patient was evaluated for possible re-intervention for the failed tav with a non-medtronic tav.Upon review of tav evaluation images, the tav frame appeared elliptical/oval shaped.There was calcification present in the sinotubular junction which had a mean diameter of <(><<)>24mm.Of note, images revealed a possible native bicuspid valve.No patient symptoms were reported as a result of this event.Additional information was received to reported that the non-medtronic tav was implanted valve-in-valve as intervention, and the patient was discharged safely.

• 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: 24750319
• Report Number: 9617601-2026-02173
• Device Sequence Number: 10215617
• Product Code: NPT
• UDI-Device Identifier: 00763000017682
• UDI-Public: (01)00763000017682(17)190829
• 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: 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
• Report Date (Section B): 05/10/2026

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: 08/29/2019
• Device Model Number: EVOLUTR-34-US
• Device Catalogue Number: EVOLUTR-34-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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/10/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male