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

Model Number	EVFXPLUS-23
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that following the implant of a transcatheter aortic valve at 3 millimeters (mm) on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc), it was observed that the valve was under expanded.Subsequently, a post-implant balloon aortic valvuloplasty was performed.Upon removal of the balloon, the valve dislodged into the sinuses.Subsequently, the valve was snared up, and a second valve was implanted valve-in-valve.It was noted that a 2 hour procedural delay occurred as a result.
Event or Problem Description
It was reported that following the implant of a transcatheter aortic valve at 3 millimeters (mm) on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc), it was observed that the valve was under expanded.Subsequently, a post-implant balloon aortic valvuloplasty (bav) was performed.Upon removal of the balloon, the valve dislodged into the sinuses.Subsequently, the valve was snared up, and a second valve was implanted valve-in-valve.It was noted that a 2 hour procedural delay occurred as a result.Additional information was received that a medtronic guidewire was used during the implant procedure, and the deployment starting point was at the bottom of the pigtail catheter.Additionally, the valve landed perfectly.Per the physician, the dislodge was caused by the balloon of the post-implant bav pulling the top struts of the valve.It was noted that no rupture or occlusion occurred.
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 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 ; 091708096
• MDR Report Key: 24690060
• Report Number: 9617601-2026-02027
• Device Sequence Number: 9976860
• Product Code: NPT
• UDI-Device Identifier: 00763000716127
• UDI-Public: (01)00763000716127(17)261226(20)01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/13/2026

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 Model Number: EVFXPLUS-23
• Device Catalogue Number: EVFXPLUS-23
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 12/26/2024
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female