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); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Medtronic received information that 12 years and 11 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.It was stated that heavy concentric calcification was noted in the sinotubular junction.No intervention or adverse patient effects were reported.Subsequently, 19 days later, a transcatheter valve was implanted valve-in-valve.The reason for intervention was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Corrections: b2 - additional checkbox ticked b5 - further event information added h6 - ime, img, fdd codes replaced, imf code added.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
Medtronic received information which stated that the reason for intervention was reported as moderate to severe aortic regurgitation (ar) and aortic stenosis (as).No additional adverse patient effects were reported.

• 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: 20512473
• Report Number: 2025587-2024-05912
• Device Sequence Number: 7044909
• Product Code: LWR
• UDI-Device Identifier: 00681490265904
• UDI-Public: 00681490265904
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 12/13/2024

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: 03/11/2014
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 04/06/2009
• 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; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female