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 Codes	Perivalvular Leak (1457); Activation Failure (3270); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rupture (2208); Pericardial Effusion (3271); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: d -evolutfx-34, serial/lot #: (b)(6), ubd: 11-apr-2027, udi#: (b)(4) h6.The codes present in section h6.Correspond to multiple components/products that comprise this reported event.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.
Event or Problem Description
It was reported that following the implant of a transcatheter aortic valve, it was observed that the valve was constrained, and there was still paravalvular leak (pvl) of unspecified severity.Subsequently, a post-implant balloon aortic valvuloplasty (bav) was performed with a non-medtronic 24 millimeter (mm) balloon.Upon closure of the access side, the patient's blood pressure dropped.It was observed via echocardiogram that pericardial effusion had occurred, and an annular rupture was later confirmed.Subsequently, the valve was explanted and the patient was sent to the intensive care unit (icu).
Event or Problem Description
Additional information was received that the severity of the pvl was moderate.Per the physician, the cause of the annular rupture was suspected to be due to the post-dilation, and the physician was not sure if the valve caused or contributed; however, the delivery catheter system (dcs) did not cause or contribute to the rupture.The patient's calcified anatomy was noted as a contributing factor to the rupture.
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.

• 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: 25203975
• Report Number: 9617601-2026-03198
• Device Sequence Number: 8981751
• Product Code: NPT
• UDI-Device Identifier: 00763000716158
• UDI-Public: (01)00763000716158(17)270131(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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?: 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: 05/15/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 01/31/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male