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 Code	Material Invagination (1336)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a valve-in-valve procedure for a patient with severe aortic stenosis and a previously implanted 19-millimeter mosaic surgical valve, a 23-millimeter evolut transcatheter aortic valve was first inspected via fluoroscopy.This inspection revealed no abnormalities to the valve, so the delivery catheter system (dcs) was advanced into the patient.Due to a challenging implantation angle, proper coaxial alignment between the transcatheter valve and the surgical bioprosthesis could not be achieved, resulting in significant difficulty in positioning the valve at the desired implantation depth.Five deployment attempts were made, and in each attempt, upon reaching approximately 80% deployment, the implantation depth was deemed suboptimal.After each attempt, the valve was fully recaptured and redeployed using the same device.During the fifth deployment attempt, at approximately 80% deployment, infolding of the valve frame was observed, which had not been noted in previous attempts.The valve was subsequently retrieved from the patient¿s body.A new valve was prepared and successfully implanted at the desired implant depth on the second deployment attempt with the use of a new dcs.The procedure was delayed due to the valve infold and positioning difficulties.
Additional Manufacturer Narrative
Updated data: b5.A second paragraph was added.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 valve-in-valve procedure for a patient with severe aortic stenosis and a previously implanted 19-millimeter mosaic surgical valve, a 23-millimeter evolut transcatheter aortic valve was first inspected via fluoroscopy.This inspection revealed no abnormalities to the valve, so the delivery catheter system (dcs) was advanced into the patient. due to a challenging implantation angle, proper coaxial alignment between the transcatheter valve and the surgical bioprosthesis could not be achieved, resulting in significant difficulty in positioning the valve at the desired implantation depth.Five deployment attempts were made, and in each attempt, upon reaching approximately 80% deployment, the implantation depth was deemed suboptimal.After each attempt, the valve was fully recaptured and redeployed using the same device.During the fifth deployment attempt, at approximately 80% deployment, infolding of the valve frame was observed, which had not been noted in previous attempts.The valve was subsequently retrieved from the patient¿s body.A new valve was prepared and successfully implanted at the desired implant depth on the second deployment attempt with the use of a new dcs.The procedure was delayed due to the valve infold and positioning difficulties.Additional information was received to report the second transcatheter valve was recaptured after the first deployment attempt to correct the position of the implant depth.The procedural delay was approximately one hour.Per the physician, the small size of the previously implant surgical aortic valve was a contributing factor to the infold.

• 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: 24434521
• Report Number: 9617601-2026-01413
• Device Sequence Number: 21408330
• Product Code: NPT
• UDI-Device Identifier: 00763000716127
• UDI-Public: (01)00763000716127(17)270429(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 02/26/2026
• Date Device Manufactured: 04/29/2025
• 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
• Patient Age: 88 YR
• Patient Sex: Female