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	Material Invagination (1336)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: d-evolutfx-34; product lot/serial number (b)(6); product type: 0195-heartvalves; implant date: non-implantable.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 the attempted implant of a transcatheter aortic valve at a target implant depth of 3 millimeters (mm), the valve was recaptured following one deployment attempt for an unspecified reason.Upon the second deployment attempt, an infold of the valve was observed.Subsequently, the valve was recaptured, and the system was withdrawn from the patient.A new valve was loaded into a new delivery catheter system (dcs) in order to complete the procedure.Per the physician, the patient's calcified anatomy contributed to the infold.No patient complications were reported as a result of this event.
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.
Event or Problem Description
It was reported that during the attempted implant of a transcatheter aortic valve at a target implant depth of 3 millimeters (mm), the valve was recaptured following one deployment attempt for an unspecified reason.Upon the second deployment attempt, an infold of the valve was observed.Subsequently, the valve was recaptured, and the system was withdrawn from the patient.A new valve was loaded into a new delivery catheter system (dcs) in order to complete the procedure.Per the physician, the patient's calcified anatomy contributed to the infold.No patient complications were reported as a result of this event.Additional information was received that the valve was recaptured following the first deployment attempted due to the valve being too aortic.Per the physician, the patient's anatomy, specifically bicuspid native valve, contributed 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: 24945223
• Report Number: 9617601-2026-02589
• Device Sequence Number: 5265135
• Product Code: NPT
• UDI-Device Identifier: 00763000716158
• UDI-Public: (01)00763000716158(17)271105(20)01
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/13/2026

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-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: 04/20/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 11/05/2025
• 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...
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 79 KG