MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. ST. JUDE TRIFECTA 23MM PROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Patient Problems Chest Pain (1776); Dyspnea (1816); Failure of Implant (1924)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Patient called to report an adverse event and device problem involving his st.Jude trifecta heart valve that he had implanted on (b)(6) 2015.Patient stated he began noticing issues such as chest pain and difficulty breathing over the course of a couple years, but never realized it could have been related to his heart valve.He stated he could feel something wasn't right.He said that eventually, he went to the cardiologist who determined he was in critical condition and within 2 weeks had his trifecta heart valve replaced.Patient stated he was told that there was not much left of the device and that it was basically gone.He said the device was defective and not working right and he realized that the failed device was the reason he felt off and was experiencing health issues.He stated he was never informed of any device problem, and that he read on-line that st.Jude was aware of problems with the trifecta heart valve and should have notified patients who had it implanted.He stated he was lucky he went to the doctor when he did.

• Brand Name: ST. JUDE TRIFECTA 23MM PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
• MDR Report Key: 17912471
• MDR Text Key: 325482101
• Report Number: MW5146799
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male