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 Code	Retroperitoneal Hemorrhage (4483)
Date of Event	08/26/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that following the implant of a transcatheter aortic valve through the femoral access site, the patient experienced retroperitoneal bleeding and died.Per the physician, the retroperitoneal bleeding was the cause of death and the patient anatomy, including a large pannus, were identified as contributing factors.
Event or Problem Description
Additional information was received indicating that per the physician, the cause of the retroperitoneal bleeding was perclose failure and inability to maintain homeostasis.Per the physician, the delivery catheter system (dcs) did not cause or contribute to the retroperitoneal bleeding.
Additional Manufacturer Narrative
D10.Continuation - concomitant medical devices in use during the event include: medtronic product id:evfxplus-26 ; product serial/lot number: r502941; product type: 0195- heart valves; implant date: (b)(6)2026; explant date: na; 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.
Additional Manufacturer Narrative
Updated: a4, b2, b3, 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.

• 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 ; +353(091)708096
• MDR Report Key: 50677588
• Report Number: 9612164-2026-04495
• Device Sequence Number: 5155384
• Product Code: NPT
• UDI-Device Identifier: 00763000716134
• UDI-Public: (01)00763000716134(17)280317(20)01
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 09/08/2026

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
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/08/2026
• 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
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 212 LB