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); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.Select patient information cannot be included in the regulatory report due to regional privacy regulations.D10.Continuation - concomitant medical devices in use during the event include: medtronic product id: evfxplus-29; serial #: (b)(6); ubd: (01)00763000979966(17)280110(21)r267636; implant date: not implanted h6.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, during preparation for the attempted implant of this 29mm transcatheter aortic bioprosthetic valve (tav) (r060870), in a patient with a type 0 bicuspid native valve, after the tav was loaded into the delivery catheter system (dcs) (0013259439) by an inexperienced valve loader, the valve load was reviewed via fluoroscopic inspection and a misload was identified.The misload was further characterized as a bent strut in the tav frame with no node involvement.The tav and dcs were not used for the procedure.A pre-implant balloon dilation was performed and a second 29mm tav (r267636) and dcs (0013259439) were loaded without issue.The dcs was inserted into the patient¿s vasculature and advanced to the aortic annulus.Three deployment attempts were made; however, the tav would dislodge and could not be implanted.The tav was recaptured into the dcs.A decision to attempt a smaller tav was made; therefore, the system was withdrawn from the patient.A third, smaller 26mm tav (r234758) was loaded into a third dcs (0013092710) without issue.The dcs was inserted into the patient¿s vasculature and advanced to the aortic annulus; however, the tav also dislodged during three separate deployment attempts and optimal tav placement could not be achieved.The tav was recaptured into the dcs and the system was withdrawn from the patient.Subsequently, a 26mm non-medtronic (sapien3 ue) tav was used to complete the procedure.Per the physician, the patient's bicuspid valve was a contributing factor to the inability to place the medtronic valves.No patient complications were reported as a result of this event.

• 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: 25331333
• Report Number: 9612164-2026-02808
• Device Sequence Number: 9881201
• Product Code: NPT
• UDI-Device Identifier: 00763000942700
• UDI-Public: (01)00763000942700(17)271022(10)0013092710(20)01
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 0013092710
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/29/2026
• Date Device Manufactured: 10/22/2025
• 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...
• Patient Sex: Unknown