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	Patient Device Interaction Problem (4001); Thickening of Material (4056)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implant procedure of this medtronic transcatheter bioprosthetic aortic valve, within a pre-existing non-medtronic valve via the right femoral access, the delivery catheter system (dcs) recaptured the medtronic valve one time due to a high position.The valve was repositioned and successfully implanted.A post implant balloon valvuloplasty was performed for an unspecified reason.Approximately 45 days following the medtronic valve-in-valve (viv) implant, hypoattenuated leaflet thickening (halt) and thromobosis within the native sinus of the medtronic valve was identified.At the time of the 30 day visit, the patient remained on an anticoagulant and a low dose aspirin.No actions or interventions were taken.Patient symptoms were not reported.The event remained resolving.The physician indicated the event was causal to the transcatheter valve.
Additional Manufacturer Narrative
Continuation of d10: product id d-evolutfx-2329; product lot/serial number (b)(6); product type: delivery catheter system; implant date n/a; explant date n/a product id l-evolutfx-2329; product lot/serial number unknown; product type: compression loading system; implant date n/a; explant date n/a product id meier wire; product lot/serial number unknown; product type: guidewire; implant date n/a; explant date n/a product id vascular balloon; product lot/serial number unknown; product type: vascular balloon; implant date n/a; explant date n/a.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: 50255261
• Report Number: 9617601-2026-05142
• Device Sequence Number: 10629720
• Product Code: NPT
• UDI-Device Identifier: 00763000716134
• UDI-Public: (01)00763000716134(17)270702(20)01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 07/02/2025
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 148 LB
• Patient Race: Asian