MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number CVD0027

Device Problem Microbial Contamination of Device (2303)

Patient Problems Death (1802); Endocarditis (1834)

Event Type  Death  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported through a research article identifying trifecta that may be related to endocarditis complicated by septic shock that led to death.Specific patient information is documented as unknown.Details are listed in the attached article, titled clinical outcome and hemodynamic performance of st.Jude trifecta aortic prosthesis: short-term follow-up and risk factors analysis.

Manufacturer Narrative

It was reported through a research article identifying trifecta that may be related to endocarditis complicated by septic shock that led to death.Specific patient information is documented as unknown.Details are listed in the article, titled clinical outcome and hemodynamic performance of st.Jude trifecta aortic prosthesis: short-term follow-up and risk factors analysis.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9111247
• MDR Text Key: 159836709
• Report Number: 3008452825-2019-00483
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CVD0027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death