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

Model Number TF-19A

Patient Problems Failure of Implant (1924); Pulmonary Valve Stenosis (2024); Cardiovascular Insufficiency (4445)

Event Date 12/04/2015

Event Type  Injury  

Event Description

The patient underwent a 19mm trifecta pulmonary valve replacement on (b)(6) 2015 for tetralogy of fallot.In (b)(6) 2019 the patient developed severe pulmonary stenosis and insufficiency requiring a balloon valvuloplasty.Then in (b)(6) 2021 the patient re-developed pulmonary stenosis requiring another balloon valvuloplasty.In (b)(6) 2023 the patient had to undergo a third balloon valvuloplasty for redevelopment of pulmonary stenosis.During the valvuloplasty it was noted that the heart valve was at 17mm.The patient does have severe insufficiency with fixed leaflets of her bioprosthetic valve, her valve true id is 17mm and cannot be expanded or fractured.The patient now has severe pulmonary insufficiency, dilated right ventricle and exercise intolerance.The team has discussed her case and the next intervention will need to be surgical valve replacement due to the size constraints of the valve.

• Brand Name: TRIFECTA HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT STRUCTURAL HEART / ABBOTT MEDICAL; alfereda GA
• MDR Report Key: 18205061
• MDR Text Key: 329134069
• Report Number: MW5148474
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF-19A
• Was Device Available for Evaluation?: No
• 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; Other
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 34 KG
• Patient Ethnicity: Hispanic