MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	FR995-23
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Thickening of Material (4056); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 8 years and 3 months post implant of this 23mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement.The reason for evaluation was not reported.No intervention or adverse patient effects were reported. subsequently 1 year 1 month later, the valve was explanted and replaced with a valve of the same size and model.  no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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
B2, b5, b7 and h6 updated.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
Additional information was received that the reason for replacement was severe aortic insufficiency and stenosis.It was reported that prior to explant, the patient experienced shortness of breath with activity and complained of significant fatigue.It was reported that during the explant procedure, it was noted that the 23mm aortic bioprosthetic valve was thickened with tears of the leaflets and there was minimal pannus ingrowth underneath the aortic annulus.No patient complications have been reported as a result of this event.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 21168639
• Report Number: 2025587-2025-00414
• Device Sequence Number: 21205762
• Product Code: LWR
• UDI-Device Identifier: 00643169002135
• UDI-Public: 00643169002135
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• 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): 03/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2016
• Device Model Number: FR995-23
• Device Catalogue Number: FR995-23
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/24/2025
• Date Device Manufactured: 12/07/2011
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 99 KG