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 Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id evfxplus-34 (b)(6); product type: 0195-heart valves; implant date: na ; explant date: na, product id l-evolutfx-34 (lot: 0012492279); 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.
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 a bicuspid aortic valve.During the attempted implant of a transcatheter valve, after advancement of a non-medtronic sheath, the delivery catheter system (dcs) was unable to advance through the left external iliac artery (eia).Subsequently, an access site dissection and perforation occurred at the left eia, and the patient¿s blood pressure dropped.Surgical repair was then initiated with the placement of a stent, and the patient was hospitalized.Per the physician, the dcs capsule or inline sheath caused the dissection.
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 a bicuspid aortic valve.During the attempted implant of a transcatheter valve, after advancement of a non-medtronic sheath, the delivery catheter system (dcs) was unable to advance through the left external iliac artery (eia).Subsequently, an access site dissection and perforation occurred at the left eia, and the patient¿s blood pressure dropped.Surgical repair was then initiated with the placement of a stent, and the patient was hospitalized.Per the physician, the dcs capsule or inline sheath caused the dissection.Additional information was received indicating that, per the physician, the primary cause of the vascular injurywas the dcs capsule.The guidewire did not contribute to the injury.The procedure was not completed and a new valve was not placed at that time.
Additional Manufacturer Narrative
Updated data: b5.Added 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.
Additional Manufacturer Narrative
Updated: a4.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: 22846139
• Report Number: 9612164-2025-04076
• Device Sequence Number: 20946854
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)260408(10)0012218011
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/17/2025

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 Expiration Date: 04/08/2026
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012218011
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 10/21/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/19/2025; 11/17/2025
• Date Device Manufactured: 04/08/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 93 KG