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

Model Number	EVOLUTFX-29
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Heart Block (4444)
Date of Event	03/02/2023
Type of Reportable Event	Death
Event or Problem Description
Medtronic received information that during implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) was pulled, causing the nosecone to dislodge the implanted valve and the patient to decompensate.An additional valve was implanted successfully.No additional adverse patient effects were reported.Additional information was received that during the implant of the valve, the right femoral artery was used for the access site.No pre-implant balloon aortic valvuloplasty (bav) was performed.A non-medtronic guidewire (safari) was used during the implant.The valve was implanted into the native annulus.Cuspal overlap technique was used along with slow deployment training guidance.It was reported that the nosecone was not centered within the valve frame inflow prior to with drawing the delivery catheter system (dcs).The dcs was not twisted or torqued during deployment.Hypotension was observe when the patient decompensated and they were placed on extracorporeal membrane oxygenation (ecmo).No additional adverse patient effects were reported.Additional information was received from a patient family member reporting it was a bad experience with putting in the device since the valve got away and had to be replaced, and the implantation of a permanent pacemaker the following day.The indication for the pacemaker was incomplete atrio-ventricular (av) block.The patient died eleven days following the valve implant procedure due to an unspecified cause.
Additional Manufacturer Narrative
Continuation of d10: product id: evolutfx-29 (serial: (b)(6)); product type: 0195-heart valves; implant date (b)(6) 2023; product id: d-evolutfx-2329 (lot: 0011517012); product type: 0195-heart valves.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVOLUT FX 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: 24202316
• Report Number: 9617601-2026-00735
• Device Sequence Number: 12133503
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: (01)00763000370701(17)241201
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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 Expiration Date: 12/01/2024
• Device Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 12/02/2022
• 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: Required Intervention; Death
• Patient Sex: Male