MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT FX LS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	L-EVOLUTFX-2329
Medical Device Problem Codes	Packaging Problem (3007); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: d-evolutfx-2329, (lot: 0012678289); product type: 0195-heart valves; implant date: na; explant date: na; select patient information cannot be included in the regulatory report due to regional privacy regulations.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that after opening the delivery catheter system (dcs) and compression loading system (cls), and while preparing to load the system, a hair was observed to be attached to the cls when cold water was added.Subsequently, a new cls was used to complete the procedure.No patient complications were reported in connection with this event.
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.
Event or Problem Description
It was reported that after opening the delivery catheter system (dcs) and compression loading system (cls), and while preparing to load the system, a hair was observed to be attached to the cls when cold water was added.Subsequently, a new cls was used to complete the procedure.No patient complications were reported in connection with this event.Additional information was received indicating that the cls sterility was compromised due to user error.The dcs sterility was not compromised.
Additional Manufacturer Narrative
Medtronic received additional information that changed the event description and device relatedness of this previously reported event.There is no evidence to suggest the device caused or contributed to a death or serious injury.There was no allegation of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device as the reported issues was caused by user.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 LS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22461483
• Report Number: 2025587-2025-04862
• Device Sequence Number: 20847677
• Product Code: NPT
• UDI-Device Identifier: 00763000942724
• UDI-Public: (01)00763000942724(17)261115(10)0012544079(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2025

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: L-EVOLUTFX-2329
• Device Catalogue Number: L-EVOLUTFX-2329
• Device Lot Number: 0012544079
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 09/24/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/24/2025
• Date Device Manufactured: 11/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown