MAUDE Adverse Event Report: ABBOTT CARDIOVASCULAR / ABBOTT MEDICAL TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number TFGT-23A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/01/2023

Event Type  Injury  

Event Description

Heart failure symptoms early in 2023 - found to have structural valve deterioration trifecta avr.Summary of tte 03/2022.Normal left ventricular size, mass and function with no significant regional wall motion abnormalities.The estimated lvef is 70%.Normal right heart size and function.Normally functioning bioprosthetic aortic valve with no significant stenosis or regurgitation.Borderline mild mitral valve stenosis with trace to mild regurgitation.Mild tricuspid valve regurgitation with estimated mildly elevated pulmonary artery systolic pressure.Compared to the prior study on (b)(6) 2020, borderline mitral valve stenosis noted today with other findings appearing similar.Summary of tte 6/2023, normal left ventricular size and systolic function with no regional abnormalities, estimated lvef is 75%.Normal right ventricular size and function.Prosthetic aortic valve with severe stenosis and moderate regurgitation.Mitral annular calcification with mild mitral stenosis and mild to moderate regurgitation.Moderate tricuspid regurgitation with estimated mildly elevated systolic pa pressure.Compared to previous (b)(6) 2022, prosthetic aortic valve dysfunction is noted.

• Brand Name: TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT CARDIOVASCULAR / ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 17209395
• MDR Text Key: 318046980
• Report Number: MW5118853
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: TFGT-23A
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White