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

Model Number	D-EVOLUTFX-2329
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the implant of a transcatheter valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to calcification.During the first advancement attempt, the valve was advanced through the right femoral artery (rfa) using an inline sheath; however, when it reached the right external iliac artery, it was unable to advance.Subsequently, the valve and delivery catheter system (dcs) were withdrawn and angioplasty and shockwave therapy were performed on the right external iliac vessel.A second advancement attempt with the same valve and dcs was then performed but was unsuccessful; therefore, the valve was withdrawn.The access site was then switched to the left femoral artery (lfa), and a new valve and dcs were advanced through a non-medtronic sheath and used to complete the procedure.It was noted that a 30-minute procedural delay occurred as a result of the event.Per the physician, the patient¿s calcified anatomy contributed to the event.
Additional Manufacturer Narrative
Continuation of d10: product id evfxplus-26 (b)(6); product type: 0195-heart valves; implant date: na ; 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 data: b5.Added second paragraph.D3.D4.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.
Event or Problem Description
It was reported that prior to the implant of a transcatheter valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to calcification.During the first advancement attempt, the valve was advanced through the right femoral artery (rfa) using an inline sheath; however, when it reached the right external iliac artery, it was unable to advance.Subsequently, the valve and delivery catheter system (dcs) were withdrawn and angioplasty and shockwave therapy were performed on the right external iliac vessel.A second advancement attempt with the same valve and dcs was then performed but was unsuccessful; therefore, the valve was withdrawn.The access site was then switched to the left femoral artery (lfa), and a new valve and dcs were advanced through a non-medtronic sheath and used to complete the procedure.It was noted that a 30-minute procedural delay occurred as a result of the event.Per the physician, the patient¿s calcified anatomy contributed to the event.Additional information was received indicating that the dcs was loaded approximately 30 minutes prior to the first advancement attempt.Of note, no misload was identified.Additional time was spent attempting to advance the dcs and this contributed to the procedural delay.No sheath was used during the first attempt at advancement.After multiple advancement attempts resulting in total time lapsed of 1 hour, the decision was made to withdraw the system.

• Brand Name: EVOLUT FX DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway CA ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway CA ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22418362
• Report Number: 2025587-2025-04803
• Device Sequence Number: 6978972
• Product Code: NPT
• UDI-Device Identifier: 00763000365691
• UDI-Public: (01)00763000365691(17)261008(10)0012480193
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/06/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0012480193
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 80 KG