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

Model Number	D-EVOLUTFX-2329
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Aortic dissection (4870); Back pain (4895)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id {evfxplus-23}; product lot/serial number (b)(6); product type: {0195-heartvalves}; implant date (b)(6) 2025; 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.
Event or Problem Description
It was reported that following the implant of a transcatheter aortic valve, while recovering, the patient reported back pain.Subsequently, a computed tomography (ct) scan was performed, revealing a dissection in the ascending aorta.Surgical intervention was performed to address the dissection.Approximately 1 week later, the patient was re-evaluated, and it was observed that the patient's respiratory condition had worsened, and they were subsequently re-intubated.Approximately 1 week later, the patient died due to an unspecified infection.
Additional Manufacturer Narrative
Updated: 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 indicating that the cause of the worsening respiratory condition was unknown; however, there was no causal relationship to the valve.The cause of death was sepsis.Per the physician, the valve did not cause or contribute to the patient's death.Per the physician, the dissection did not cause or contribute to the patient's 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.
Event or Problem Description
It was reported that following the implant of a transcatheter aortic valve, while recovering, the patient reported back pain.Subsequently, a computed tomography (ct) scan was performed, revealing a dissection in the ascending aorta.Surgical intervention was performed to address the dissection.Approximately 1 week later, the patient was re-evaluated, and it was observed that the patient's respiratory condition had worsened, and they were subsequently re-intubated.Approximately 1 week later, the patient died due to an unspecified infection.Additional information was received indicating that the cause of the worsening respiratory condition was unknown; however, there was no causal relationship to the valve.The cause of death was sepsis.Per the physician, the valve did not cause or contribute to the patient¿s death.Per the physician, the dissection did not cause or contribute to the patient¿s death.Additional information was received that clarified surgical intervention was not performed.Additional information was received that prior to the implant procedure of the transcatheter valve, the patient's blood pressure was load.Following the procedure, the patient's blood pressure was controlled with antihypertensive medication.It was clarified that patient was placed under observation for the dissection, and there was no treatment/intervention.
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.
Event or Problem Description
It was reported that following the implant of a transcatheter aortic valve, while recovering, the patient reported back pain.Subsequently, a computed tomography (ct) scan was performed, revealing a dissection in the ascending aorta.Surgical intervention was performed to address the dissection.Approximately 1 week later, the patient was re-evaluated, and it was observed that the patient's respiratory condition had worsened, and they were subsequently re-intubated.Approximately 1 week later, the patient died due to an unspecified infection.Additional information was received indicating that the cause of the worsening respiratory condition was unknown; however, there was no causal relationship to the valve.The cause of death was sepsis.Per the physician, the valve did not cause or contribute to the patient¿s death.Per the physician, the dissection did not cause or contribute to the patient¿s death.Additional information was received that clarified surgical intervention was not performed.

• 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: 23964543
• Report Number: 9612164-2026-00052
• Device Sequence Number: 4888090
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: (01)00763000365677(17)270130(10)0012648577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 03/11/2026

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: 0012648577
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/03/2026; 03/04/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/29/2026; 03/02/2026; 03/11/2026
• Date Device Manufactured: 01/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown