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

Model Number	D-EVOLUTFX-2329
Medical Device Problem Codes	Difficult to Advance (2920); Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed, which was standard for the implanting physician.During insertion of the delivery catheter system (dcs) through the right femoral artery, difficulty inserting and advancing the dcs occurred.Subsequently, a material protrusion was observed.It was noted that the minimum diameter of the vessel was 5 millimeter¿s (mm).The dcs was withdrawn from the patient over the guidewire.A new valve and dcs were prepared.While advancing the dcs through the right femoral artery, an iliac rupture was identified.Subsequently, surgical repair of the vessel was performed.Per the physician, the cause of the iliac rupture was due to the patients iliac disease.
Additional Manufacturer Narrative
Continuation of d10: product id {evfxplus-26}; product lot/serial number {(b)(6)}; product type: {0195-heart valves}; implant date {n/a}; explant date {n/a} 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 attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed, which was standard for the implanting physician.During insertion of the delivery catheter system (dcs) through the right femoral artery, difficulty inserting and advancing the dcs occurred.Subsequently, a material protrusion was observed.It was noted that the minimum diameter of the vessel was 5 millimeter's (mm).The dcs was withdrawn from the patient over the guidewire.A new valve and dcs were prepared.While advancing the dcs through the right femoral artery, an iliac rupture was identified.Subsequently, surgical repair of the vessel was performed.Per the physician, the cause of the iliac rupture was due to the patients iliac disease.Additional information was received indicating that the valve implant procedure was completely aborted following repair of the vessel.According to the physician, the two evolut fx delivery systems did not contribute to the access site rupture.
Additional Manufacturer Narrative
Additional information: b5 (second paragraph).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: 23367148
• Report Number: 9612164-2025-05238
• Device Sequence Number: 9118467
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: (01)00763000365677(17)270528(10)0012840423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/20/2025

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: 0012840423
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 05/28/2025
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 66 KG