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-26-US
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Thickening of Material (4056)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	01/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that 8 years and 9 months following the implant of a transcatheter aortic valve, an unspecified valve failure occurred.
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.Adverse event and product problem.B2.Outcome attributed to adverse event.The patient's date of death.B5.A second paragraph was added.H1.The original information indicated the event was a reportable malfunction.Additional information indicated the patient died.The event is now a reportable death.H6.Annex e code and annex a code (a040612) additional codes.Correct data: h6.Annex a code (a01) was added as it was erroneously omitted from the initial medwatch report.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 9 months following the implant of a transcatheter aortic valve, an unspecified valve failure occurred.Additional information was previously reported, but not captured in the initial narrative: possible thrombus/pannus inside of the valve frame was observed on computed tomography scan.Two days later, the patient died.According to the published obituary, the patient¿s death was related to unspecified cardiac complications.No further information will be made available.
Additional Manufacturer Narrative
Updated data: h2 h3 h6.Image review: a case report and one 3mensio video clip from imaging services were provided.The evolut valve is positioned within a surgical aortic valve (sav), with radiopaque sutures visible near the device.Report review: the computed tomography (ct) imaging is affected by artifact and appears blurry.The evolut implant is well expanded, with no obvious calcification noted.Implant depth measures 2.1 millimeter (mm) beneath the right coronary cusp (rcc), 1.3 mm beneath the left coronary cusp (lcc), and 3.4 mm beneath the non-coronary cusp (ncc).There is a possible pannus or thrombus within the transcatheter aortic valve (tav) frame versus inadequate contrast filling.A mosaic surgical aortic valve (sav) is noted, with radiopaque sutures visible near the device.Additionally, there is a possible thrombus versus inadequate contrast filling in the left atrial appendage (laa).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: 24183902
• Report Number: 9617601-2026-00621
• Device Sequence Number: 10016937
• Product Code: NPT
• UDI-Device Identifier: 00643169637993
• UDI-Public: (01)00643169637993(17)181105
• 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: 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
• Report Date (Section B): 02/24/2026

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: 11/05/2018
• Device Model Number: EVOLUTR-26-US
• Device Catalogue Number: EVOLUTR-26-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: 01/21/2026
• Supplement Date Received by Manufacturer: Not provided; 01/28/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/16/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2016
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Male