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

Model Number	D-EVOLUTFX-2329
Medical Device Problem Codes	Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Valvular Insufficiency/ Regurgitation (4449)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to calcification.Following implant of the valve in the patient¿s native annulus, upon withdrawing the delivery catheter system (dcs), the nosecone caught on the outflow of the valve despite the nosecone of the dcs being centered while retracting the dcs through the valve inflow.Subsequently, the valve dislodged, resulting in a final valve implant depth of -5 millimeter's (mm) on the non-coronary cusp (ncc) and 0 mm's on the left coronary cusp (lcc).It was noted that a non-medtronic guidewire was used during the procedure.Trace paravalvular leak (pvl) was observed in the valve, as well as a gradient of 8 millimeters of mercury (mm hg).As a result, the patient was monitored in the hospital, and the patient's hospitalization was prolonged.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: evfxplus-26, serial/lot #: (b)(6), ubd: 14-apr- 2027, udi#: (b)(4) the codes present in section h6 correspond to multiple components/products that comprise this reported event.Image review: one static image was provided for review.The patient¿s executive summary was provided for anatomical review.The patient¿s annulus perimeter measured 67.8mm with a perimeter derived diameter of 21.6 mm suggesting a 26mm valve.The dislodgement event was not captured; however, it was reported that the nose cone interacted with the valve frame causing it to dislodge above the aortic annulus.Use caution while withdrawing the delivery catheter system to minimize interaction with the valve frame.As stated in the instructions for use (ifu), potential risks associated with the implantation of the evolut fx+ bioprosthesis may include, but are not limited to, the following: prosthetic valve migration/embolization.It was reported that trace paravalvular leak was observed and a gradient of 8mmhg, therefore no intervention was performed.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
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 data: 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.

• 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: 23402274
• Report Number: 9612164-2025-05298
• Device Sequence Number: 10084229
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: (01)00763000365677(17)270513(10)0012812273
• 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,Followup,Followup
• Report Date (Section B): 12/22/2025

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: 0012812273
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 11/27/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/24/2025; 12/22/2025
• Date Device Manufactured: 05/13/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 100 KG