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

Model Number	D-EVOLUTFX-34
Medical Device Problem Codes	Failure to Advance (2524); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: evfxplus-34 (serial: (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 valve, the 18 french (fr) non-medtronic sheath was difficult to advance.Subsequently, a shockwave procedure was performed with a 12 millimeter (mm) balloon, and the 18 fr sheath was advanced.The valve was crossed and a pre-implant balloon aortic valvuloplasty (bav) was performed due to calcification.However, during delivery catheter system (dcs) advancement, the dcs was unable to advance through the left common iliac artery.Subsequently, the procedure was aborted, and the patient was transferred to surgery due to an iliac dissection.Per the physician, the patient's calcified anatomy contributed to the event.
Additional Manufacturer Narrative
Updated data: b5.Second paragraph added d4.H4.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 attempted implant of a transcatheter valve, the 18 french (fr) non-medtronic sheath was difficult to advance.Subsequently, a shockwave procedure was performed with a 12 millimeter (mm) balloon, and the 18 fr sheath was advanced.The valve was crossed and a pre-implant balloon aortic valvuloplasty (bav) was performed due to calcification.However, during delivery catheter system (dcs) advancement, the dcs was unable to advance through the left common iliac artery.Subsequently, the procedure was aborted, and the patient was transferred to surgery due to an iliac dissection.Per the physician, the patient's calcified anatomy contributed to the event.Additional information was received that the left femoral artery was used as the dcs access site with a minimum diameter of 5.9mm in the left common iliac artery.It was noted that a balloon angioplasty was performed two days prior to the attempted valve implant.Per the physician, the non-medtronic sheath caused the dissection.

• 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: 23696371
• Report Number: 9612164-2025-05972
• Device Sequence Number: 21113195
• Product Code: NPT
• UDI-Device Identifier: 00763000942717
• UDI-Public: (01)00763000942717(17)270226(10)0012690271(20)01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/06/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012690271
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 02/26/2025
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 76 KG