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

Model Number	L-EVOLUTFX-2329
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e vfxplus-29, serial/lot #: (b)(6), ubd: 11-apr-2027, udi #: (b)(4); product id: evfxplus-29, serial/lot #: (b)(6), ubd: 05-sep-2027, udi #: (b)(4).The codes present in section h6 correspond to multiple components/products that comprise this reported event.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 prior to the implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to the patient's thickened leaflets.Following the successful deployment of the valve, upon the removal of the delivery catheter system (dcs), the nose cone caught on the valve frame, resulting in dislodgement of the valve.Subsequently, a new valve and dcs were prepped.Upon the first deployment attempt with the second system, the valve was unable to be positioned securely and was subsequently recaptured.Two further deployment attempts were made, however the valve remained unable to be securely positioned.Subsequently, the procedure was ultimately aborted.Per the physician, the patient's tortuous anatomy including a 70 degree root angle, short aortic root, and leaflet calcification contributed to the dislodge and the difficulties placing the second valve.
Additional Manufacturer Narrative
Additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.Updated data: h6.H10.The correct devices are documented in the related reports additional codes.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 LS
• 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: 24183906
• Report Number: 9612164-2026-00471
• Device Sequence Number: 10016940
• Product Code: NPT
• UDI-Device Identifier: 00763000365691
• UDI-Public: (01)00763000365691(17)270318(10)0012721953
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 02/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: L-EVOLUTFX-2329
• Device Catalogue Number: L-EVOLUTFX-2329
• Device Lot Number: 0012721953
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/20/2026
• Date Device Manufactured: 03/18/2025
• 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: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 68 KG