MAUDE Adverse Event Report: MEDTRONIC IRELAND EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVOLUTFX-2329
Medical Device Problem Codes	Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	03/16/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: evolutfx-29, serial/lot #: (b)(6), ubd: 07-jul-2027, udi#: (b)(4).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 prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed.Following the bav, the patient began to experience severe aortic insufficiency.Upon the first deployment attempt of the valve, the valve dislodged while still attached to the delivery catheter system (dcs).Subsequently, a recapture was performed.Upon the second deployment attempt, severe paravalvular leak (pvl) was observed, and a second recapture was performed.The severe pvl remained following a third deployment attempt, and subsequently the physician decided to upsize to a 34 millimeter (mm) valve, so the 29 mm system was withdrawn from the patient.It was observed that the patient had gone into cardiac arrest, and 50 minutes of advanced cardiopulmonary resuscitation (cpr) were performed.The valve was deployed and successfully implanted during the cardiac arrest, however ventricular contraction was absent in the final echocardiogram, and the patient was declared dead.
Additional Manufacturer Narrative
Corrected data: b5.Updated data: a4, b5, d4, h4.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
Information was omitted from the initial event narrative indicating that following the implant of the second valve, the valve was confirmed to be properly implanted and other complications were ruled out by echocardiogram and angiography.Additional information was received that per the physician, the 29 mm valve, 34 mm valve and first dcs did not cause or contribute to the cardiac arrest.
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.Following the bav, the patient began to experience severe aortic insufficiency.Upon the first deployment attempt of the valve, the valve dislodged while still attached to the delivery catheter system (dcs).Subsequently, a recapture was performed.Upon the second deployment attempt, severe paravalvular leak (pvl) was observed, and a second recapture was performed.The severe pvl remained following a third deployment attempt, and subsequently the physician decided to upsize to a 34 millimeter (mm) valve, so the 29 mm system was withdrawn from the patient.It was observed that the patient had gone into cardiac arrest, and 50 minutes of advanced cardiopulmonary resuscitation (cpr) were performed.The valve was deployed and successfully implanted during the cardiac arrest, however ventricular contraction was absent in the final echocardiogram, and the patient was declared dead.Information was omitted from the initial event narrative indicating that following the implant of the second valve, the valve was confirmed to be properly implanted and other complications were ruled out by echocardiogram and angiography.Additional information was received that per the physician, the 29 mm valve, 34 mm valve and first dcs did not cause or contribute to the cardiac arrest.Additional information was received that prior to the implant procedure; the patient had a pre-existing left ventricular ejection fraction (lvef) of 25%.Per the physician, the cause of the cardiac arrest was due to poor cardiac reserve.
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 was received that per the physician, the cause of death was due to cardiac arrest.Per the physician, the 29 mm valve, 34 mm valve, and both dcs could be ruled out as contributing factors to the death.
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 DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24639258
• Report Number: 9612164-2026-01405
• Device Sequence Number: 9895023
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: (01)00763000365677(17)270311(10)0012710777(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 05/05/2026

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: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0012710777
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 04/27/2026; 05/04/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/08/2026; 04/29/2026; 05/05/2026
• Date Device Manufactured: 03/11/2025
• 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: Life Threatening; Death; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 60 KG