MAUDE Adverse Event Report: ABBOTT ST. JUDE MEDICAL ST JUDE TRIFECTA BIOPROSTHETIC AORTIC VALVE 25MM; HEART-VALVE, MECHANICAL

Model Number 25MM

Patient Problems Chest Pain (1776); Dyspnea (1816); Dizziness (2194); Lethargy (2560)

Event Date 12/23/2023

Event Type  Injury  

Event Description

Experienced episodes of dizziness, chest pain, arm pain, shortness of breath, lethargic, unable to lie down.It passed.Then, happened again a few days later and was taken to er.Sent home the same day.Worsening episodes to include belching, and not hungry.Returned to hospital 1/25/2024.Diagnosed (b)(6) 2024 with severe prosthesis stenosis of a st.Jude trifecta bioprosthetic aortic valve.Patient was transferred to (b)(6) and is awaiting possible tavr procedure currently.

• Brand Name: ST JUDE TRIFECTA BIOPROSTHETIC AORTIC VALVE 25MM
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT ST. JUDE MEDICAL
• MDR Report Key: 18614244
• MDR Text Key: 334310656
• Report Number: MW5150926
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 01/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 25MM
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White