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

Model Number	D-EVOLUTFX-2329
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/06/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Select patient information cannot be included in regulatory report due to regional privacy regulations.Section d information references the main component of the system.Other relevant device(s) are: product id: evfxplus-26, serial/lot #: (b)(6), ubd: 12-aug-2027, udi #: (b)(4).The codes present in section h6 correspond to multiple components/products that comprise this reported event.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, the valve was successfully implanted.Upon withdrawing the wire, the valve was pulled and dislodged.A snare was used to stabilize the dislodged valve in the ascending aorta, and a second valve was implanted.Immediately after the implant of the second valve, hypotension and bradycardia were observed.An echocardiogram was performed that revealed a large pericardial effusion.Subsequently, resuscitation was performed, including cardiac massage, temporary pacing, and pericardial drainage.Emergency surgery was performed via left anterior thoracotomy in the apical area.At the end of the procedure, bleeding had ceased and the patient was hemodynamically stable.Approximately 5 hours following the implant procedure, the patient died.The physician assessed that during the implant of the second valve, the medtronic guidewire caused a left ventricle perforation that resulted in tamponade and subsequent death.Per the physician, the event was a procedure related complication, with no claims against the valve or delivery catheter system (dcs).
Event or Problem Description
It was reported that following the successful implant of a transcatheter valve, upon withdrawing the wire, the valve was pulled and dislodged.A snare was used to stabilize the dislodged valve in the ascending aorta, and a second valve was implanted.Immediately after the implant of the second valve, hypotension and bradycardia were observed.An echocardiogram was performed that revealed a large pericardial effusion.Subsequently, resuscitation was performed, including cardiac massage, temporary pacing, and pericardial drainage.Emergency surgery was performed via left anterior thoracotomy in the apical area.At the end of the procedure, bleeding had ceased and the patient was hemodynamically stable.Approximately 5 hours following the implant procedure, the patient died.The physician assessed that during the implant of the second valve, the medtronic (confida) guidewire caused a left ventricle perforation that resulted in tamponade and subsequent death.Per the physician, the event was a procedure related complication, with no claims against the valve or delivery catheter system (dcs).Additional information was received that a pre-implant balloon dilation was not performed and a medtronic (confida) guidewire was used for the procedure.The guidewire was introduced and placed into the apex of the left ventricle through a catheter that was already positioned in the ventricle.The guidewire position was monitored throughout the procedure.The direction of dislodgement was aortic.The physician reported that the patient's frail, elderly condition and underlying pulmonary edema were contributing factors to the event.The physician excluded both the first and second valve and dcs used as contributing causes to the death.
Additional Manufacturer Narrative
Updated: 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.

• 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: 24006153
• Report Number: 9612164-2026-00115
• Device Sequence Number: 4888266
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: (01)00763000365677(17)260921(10)0012454239
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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 Expiration Date: 09/21/2026
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0012454239
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 09/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 89 YR
• Patient Sex: Female