MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-34
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed with a non-medtronic 23 millimeter (mm) balloon due to the patient's calcified and bicuspid native valve.Upon deployment of the first 3-4 nodes of the valve, it was identified that the valve was positioned too high relative to the target implant depth of 2 mm on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc).Subsequently, the valve was recaptured into the delivery catheter system (dcs).Upon the second deployment attempt, an infold was identified.Subsequently, the valve was recaptured, and the system was withdrawn from the patient.An additional pre-implant bav was performed with a non-medtronic 25 mm balloon, and a new valve and dcs were opened and prepped.The second valve was implanted successfully, however the patient went into complete heart block (chb) following the release of the valve.The following day, a permanent pacemaker was implanted for the chb.Per the physician, the patient's bicuspid native valve and calcified anatomy contributed to the infold.A 10 minute procedural delay occurred as a result.
Additional Manufacturer Narrative
This is a system report.The section d.Information is for the primary device, which was in use with the following device(s) which cannot be excluded as potential contributing factors to the adverse event: product id: d-evolutfx-34; manufactured date: unknown; fda site id: p1041.H6.The codes present in section h6.Correspond to multiple components/products that comprise this reported event.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 FX PLUS 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 ; +353(091)708096
• MDR Report Key: 50936256
• Report Number: 9617601-2026-05856
• Device Sequence Number: 10759860
• Product Code: NPT
• UDI-Device Identifier: 00763000716158
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: EVFXPLUS-34
• Device Catalogue Number: EVFXPLUS-34
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 08/05/2025
• 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: Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male