MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTFX-29
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Chest Pain (1776); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Thromboembolism (2654); Thrombosis/Thrombus (4440)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one hour following the implant of the transcatheter bioprosthetic aortic valve the patient arrived in the intensive cardiac care unit (iccu) as chest pain developed.An electrocardiogram (ecg) identified st elevation in the lateral leads.The patient was taken back to the catheterization laboratory.On arrival to the laboratory, the chest pain abated and the ecg returned to baseline.A periprocedural myocardial infarction occurred.The coronary angiography identified a ¿small¿ distal thrombus in the saphenous vein grafted to the circumflex.As reported calcium from the calcified valve embolized during the transcatheter valve procedure.An arteriography was performed and unspecified conservative treatment provided.No further symptoms occurred during the prolonged hospitalization.The physician indicated the event was probably related to the transcatheter valve procedure but unrelated to the medtronic products.The event resolved the same date as onset.
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 (b)(6); product type: compression loading system; implant date n/a; explant date n/a.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.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
Updated data: b5, h6 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
Additional information received indicated that a cardiac computed tomography (ct) scan was performed approximately 1 week prior to the transcatheter valve implant.This ct identified calcified peripheral arteries and a tricuspid aortic valve with calcium score of 1523 units.The aortic annulus was without calcifications or aortomitral continuity.The coronary angiography noted the right coronary artery was unchanged with diffuse disease at 90%.An arterial graft to the left anterior descending (lad) was patent.As further clarified, a thrombus in the very distal portion of the venous graft to the obtuse marginal (om) 1+2 was identified.During the catheterization, no chest pain presented and the electrocardiogram (ecg) was without st elevations.As reported, it was likely an embolus that occurred which progressed distally.The conclusion was conservative treatment and heparinization for 24 hours.The patient returned to the intensive cardiac care unit (iccu) for continued treatment.
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
Additional information received indicated conservative treatment included observation of the patient during admission.

• Brand Name: EVOLUT FX 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: 24442914
• Report Number: 9617601-2026-01423
• Device Sequence Number: 10364046
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: (01)00763000370701(17)260111
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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 Expiration Date: 01/11/2026
• Device Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 05/06/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/23/2026; 05/06/2026
• Date Device Manufactured: 01/12/2024
• 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; Life Threatening; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG