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); Patient Device Interaction Problem (4001); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Calcium Deposits/Calcification (1758); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	07/08/2024
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 13 years and 10 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a 25mm aortic bioprosthetic valve of the same model.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated a4 updated b1 updated b2 updated b3 updated b5 updated b7 updated h6 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 additional information which stated that 13 years and 8 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a aortic mechanical valve of a different manufacturer.It was stated that the patient had been experiencing progressive shortness of breath (sob).The patient developed atrial fibrillation (afib) with rapid ventricular response (rvr) and was admitted to hospital.It was revealed that there was moderate to severe aortic stenosis (as) of the valve with suspected vegetation on an aortic leaflet and severe aortic insufficiency (ai).It was noted during explant that there was a lot of calcifications in the left ventricular outflow tract (lvot).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: 20351837
• Report Number: 2025587-2024-05468
• Device Sequence Number: 8108239
• Product Code: LWR
• UDI-Device Identifier: 00681490265904
• UDI-Public: 00681490265904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 10/30/2024

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: 09/30/2015
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/30/2024
• Date Device Manufactured: 11/03/2010
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 83 KG