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

Model Number	D-EVOLUTFX-2329
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Rupture (2208); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	05/12/2026
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: evfxplus-26, serial/lot #: (b)(6), ubd: 10-sep-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 prior to the attempted implant of a transcatheter aortic valve, it was decided to use the left common carotid artery as the access site due to tortuosity in the abdominal aorta.Subsequently, a pre-implant balloon aortic valvuloplasty (bav) was performed with a non-medtronic 23 millimeter (mm) balloon.Upon the first deployment attempt, it was observed that the positioning of the valve was "catastrophically" deep.Subsequently, the device was pulled back into the patient's ascending aorta to increase the patient's blood pressure.Levophed was administered, with no increase to the patient's blood pressure.It was observed via transesophageal echocardiogram (tee) that a circumferential pericardial effusion had occurred, with hemodynamic changes that corresponded to cardiac tamponade.Cpr was initiated and pericardial window was attempted, however the effusion and blood pressure did not improve after 30 minutes, and the patient ultimately died.An annular rupture was suspected, but was unable to be confirmed.Per the physician, the use of the left common carotid artery as the access site contributed to the event.A 30 minute procedural delay occurred as a result.
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 was received that per the physician, the cause of the injury was possibly the bav, the working guidewire, or the valve; however, the delivery catheter system did not cause or contribute to the injury.
Event or Problem Description
It was reported that prior to the attempted implant of a transcatheter aortic valve, it was decided to use the left common carotid artery as the access site due to tortuosity in the abdominal aorta.Subsequently, a pre-implant balloon aortic valvuloplasty (bav) was performed with a non-medtronic (beckton dickson true) 23 millimeter (mm) balloon.Upon the first deployment attempt, it was observed that the positioning of the valve was "catastrophically" deep.Subsequently, the device was pulled back into the patient's ascending aorta to increase the patient's blood pressure.Levophed was administered, with no increase to the patient's blood pressure.It was observed via transesophageal echocardiogram (tee) that a circumferential pericardial effusion had occurred, with hemodynamic changes that corresponded to cardiac tamponade.Cpr was initiated and pericardial window was attempted, however the effusion and blood pressure did not improve after 30 minutes, and the patient ultimately died.An annular rupture was suspected, but was unable to be confirmed.Per the physician, the use of the left common carotid artery as the access site contributed to the event.A 30 minute procedural delay occurred as a result.Additional information was received that per the physician, the cause of the injury was possibly the bav, the working guidewire, or the valve; however, the delivery catheter system did not cause or contribute to the injury.Additional information was received to report a non-medtronic (boston scientific safari) guidewire was used for the case.
Additional Manufacturer Narrative
Updated data: d10.Continuation - concomitant medical devices in use during the event include: non-medtronic product id: boston scientific safari guidewire; lot #: unknown; ubd: unknown; implant date: non-implantable.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: 25176744
• Report Number: 9612164-2026-02515
• Device Sequence Number: 10566379
• Product Code: NPT
• UDI-Device Identifier: 00763000942700
• UDI-Public: (01)00763000942700(17)280204(10)0013274836(20)01
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2026

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: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0013274836
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 06/24/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/24/2026; 07/20/2026
• Date Device Manufactured: 02/04/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Death; Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female