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

Model Number	EVOLUTPRO-26-US
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Coronary obstruction/occlusion (4871)
Date of Event	04/08/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of d10: product id: envpro-16; product lot/serial number (b)(6); product type: {0195-heartvalves}; implant date {non-implantable} select patient information cannot be included in the regulatory report due to regional privacy regulations.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 following the successful implant of a transcatheter aortic valve, a coronary occlusion occurred.It was attempted to restore coronary flow, however it was unsuccessful, resulting in cardiac arrest.Extracorporeal membrane oxygenation (ecmo) was initiated, however due to the prolonged duration of resuscitation, it was assessed that open chest intervention would have limited benefit, and the patient ultimately died.
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
It was reported that following the successful implant of a transcatheter aortic valve, a coronary occlusion occurred.It was attempted to restore coronary flow, however it was unsuccessful, resulting in cardiac arrest.Extracorporeal membrane oxygenation (ecmo) was initiated, however due to the prolonged duration of resuscitation, it was assessed that open chest intervention would have limited benefit, and the patient ultimately died.Additional information was received that per the physician, the valve and delivery catheter system (dcs) did not cause or contribute to the coronary occlusion.
Event or Problem Description
It was reported that following the successful implant of a transcatheter aortic valve, a coronary occlusion occurred.It was attempted to restore coronary flow, however it was unsuccessful, resulting in cardiac arrest.Extracorporeal membrane oxygenation (ecmo) was initiated, however due to the prolonged duration of resuscitation, it was assessed that open chest intervention would have limited benefit, and the patient ultimately died.Additional information was received that per the physician, the valve and delivery catheter system (dcs) did not cause or contribute to the coronary occlusion.Additional information was received that the transcatheter valve did not dislodge and occlude the coronary ostia, and the dcs did not dislodge calcium/plaque that occluded the coronary artery.Per the physician, the cause of death was due to valve leaflet obstruction of the coronary artery; however, the transcatheter valve and dcs can be excluded as contributing factors to the death.
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.

• Brand Name: EVOLUT PRO 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: 24862453
• Report Number: 9617601-2026-02435
• Device Sequence Number: 10493598
• Product Code: NPT
• UDI-Device Identifier: 00763000017828
• UDI-Public: (01)00763000017828(17)270407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: EVOLUTPRO-26-US
• Device Catalogue Number: EVOLUTPRO-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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/19/2026; 04/22/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/20/2026; 04/23/2026
• Date Device Manufactured: 06/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 90 KG