MAUDE Adverse Event Report: MEDTRONIC IRELAND EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVOLUTFX-2329
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Perforation (2513)
Date of Event	12/01/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that prior to the attempted implantation of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to the presence of a previously implanted non-medtronic aortic valve that had failed.The delivery catheter system (dcs) was advanced through the patients right femoral artery, which had a minimum diameter of 4.6 millimeter's (mm).During the procedure, a left ventricle perforation was observed.Subsequently, the dcs was withdrawn from the patient without implantation of the valve.As the dcs was being withdrawn, a perforation was noted at the access site.Subsequently, a stent was placed in the patients right femoral artery and pericardiocentesis was performed.The patient was taken to the operating room for surgery, but the patient ultimately died.Per the physician, the left ventricle perforation was the cause of death.Additionally, the physician reported that the procedure contributed to the patient death, and the dcs in combination with the patients calcified anatomy and failed non-medtronic valve contributed to the access site perforation.
Additional Manufacturer Narrative
Continuation of d10: product id {evfxplus-29}; product lot/serial number (b)(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.
Additional Manufacturer Narrative
Additional information was received indicating that some of the information previously reported applied to a different device/patient.This medwatch has been corrected and information pertaining to the other device was submitted on the report number referenced in h10.Corrected: a1, a2, 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 during a transcatheter aortic valve implant procedure, a left ventricle perforation occurred.The valve was not implanted.Pericardiocentesis was performed and the patient was taken to the operating room (or) for surgery.The patient subsequently died the same day.The physician indicated that the procedure contributed to the death.

• Brand Name: EVOLUT FX DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23760981
• Report Number: 9612164-2025-06092
• Device Sequence Number: 10075803
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: (01)00763000365677(17)270102(10)0012606112
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/12/2026

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: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0012606112
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 01/02/2025
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female