MAUDE Adverse Event Report: ABBOTT MEDICAL, INC. TRIFECTA GT AORTIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TFGT-25A

Patient Problems Dyspnea (1816); Failure of Implant (1924); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/23/2023

Event Type  Injury  

Event Description

I had aortic valve replaced in december 2016 with a abbott trifecta gt.I was informed valve would last 10 to 20 years on average.I was hospitalized in (b)(6) 2023 as i could not breathe and was diagnosed with congested heart failure due to sudden aortic valve failure.I had open heart surgery to remove the trifecta gt valve and all associated parts it was replaced by a different manufacturers valve.Upon removal the trifecta valve was found to have severe stenosis and two of the three leaflets were torn per surgeon.I am truly blessed to be alive.Heart catheterization, mri, ekg, heart ultra sound, x ray, blood work.

• Brand Name: TRIFECTA GT AORTIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL, INC.
• MDR Report Key: 17372044
• MDR Text Key: 319576979
• Report Number: MW5119778
• 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: Patient
• Type of Report: Initial
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: TFGT-25A
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN ; LISINOPRIL; METOPROLOL
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening; Disability
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White