MAUDE Adverse Event Report: Medtronic Ireland EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVOLUTFX-2329
Medical Device Problem Codes	Unintended Collision (1429); Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Valvular Insufficiency/ Regurgitation (4449); Aortic dissection (4870)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury

• 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: 50564285
• Report Number: 9612164-2026-04392
• Device Sequence Number: 15941527
• Product Code: NPT
• UDI-Device Identifier: 00763000942700
• UDI-Public: (01)00763000942700(17)280615(10)0013498735(20)01
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 09/30/2026

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: 0013498735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 06/16/2026
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female