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	Perivalvular Leak (1457); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiovascular Dysfunction/Insufficiency (4445); Valvular Insufficiency/ Regurgitation (4449); Coronary obstruction/occlusion (4871)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to the patient's calcified anatomy.Following insertion of the delivery catheter system (dcs) into the patient, on the first deployment attempt, it was observed that the valve was positioned too shallow in relation to the target implant depth.Subsequently, the valve was recaptured into the dcs.Upon the second deployment attempt, the valve was positioned too deep relative to the target implant depth.Subsequently, a second recapture was performed.On the third deployment attempt, the valve was implanted successfully, however paravalvular leak (pvl) of unspecified severity was observed.Subsequently, a post-implant bav was performed with a non-medtronic 22 millimeter (mm) balloon.The final angiogram revealed no pvl and patent flow in both coronary arteries.An echocardiogram assessment was being performed when the patient was observed to be hypotensive.Echocardiogram and coronary angiography revealed a partially obstructed left main coronary artery due, resulting in diminished flow.A stent was placed into the left main coronary artery.Per the physician, the patient's heavily calcified left main coronary artery leaflet contributed to the obstruction.
Additional Manufacturer Narrative
Continuation of d10: product id {d-evolutfx-2329}; product lot/serial number {unknown}; product type: {0195-heartvalves}; implant date {non-implantable} this report was impacted by emdr scheduled maintenance occurring (b)(6), 2026.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: 50087289
• Report Number: 9617601-2026-04609
• Device Sequence Number: 15953030
• Product Code: NPT
• UDI-Device Identifier: 00763000716134
• UDI-Public: (01)00763000716134(17)280328(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/02/2026

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: 07/22/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 03/29/2026
• 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: Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female