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

Model Number	FR995-29
Medical Device Problem Codes	Calcified (1077); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Vascular Dissection (3160); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/03/2025
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
It was reported that a patient implanted with an aortic bioprosthetic valve was being evaluated for a transcatheter valve-in-valve re placement.The reason for evaluation was not reported.It was noted that protruding calcification was seen in the sinotubular junction (stj) and a possible dissection was seen throughout the ascending arch, aortic arch, and descending thoracic aorta.No intervention or adverse patient effects were reported.It was further reported that the patient was hospitalized on the same day for an urgent valve-in-valve procedure due to severe aortic regurgitation.The procedure was performed using an transcatheter aortic valve of a different manufacturer.The procedure and immediate recovery were unremarkable.

• 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: 21214988
• Report Number: 2025587-2025-00550
• Device Sequence Number: 3467457
• Product Code: LWR
• UDI-Device Identifier: 00681490816465
• UDI-Public: 00681490816465
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 09/16/2012
• Device Model Number: FR995-29
• Device Catalogue Number: FR995-29
• 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: 01/03/2025
• Initial Report FDA Received Date: 01/23/2025
• Date Device Manufactured: 04/05/2012
• 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; Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 95 KG