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

Model Number	EVFXPLUS-26
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bradycardia (1751); Tachycardia (2095)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information was received that the valve was implanted into a patient with severe aortic insufficiency.The first valve dislodged ventricular and was snared up into the ascending aorta.Subsequently a second valve was implanted.
Event or Problem Description
It was reported that following the implant of a transcatheter aortic valve, a second valve was implanted valve-in-valve for an unspecified reason.An id card was sent with the serial number of the valve that was initially implanted, and replaced.Subsequently, the serial number was corrected, and a new id card with a data correction letter was sent.Approximately 6 days later, a permanent pacemaker was implanted for brady/tachy syndrome.
Additional Manufacturer Narrative
Updated a.4, b.5 and h.6.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.
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.

• 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: 50253405
• Report Number: 9617601-2026-05135
• Device Sequence Number: 18659680
• Product Code: NPT
• UDI-Device Identifier: 00763000716134
• UDI-Public: (01)00763000716134(17)280325(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/11/2026

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-26
• Device Catalogue Number: EVFXPLUS-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 03/26/2026
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 121 LB