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

Model Number TF-27A

Device Problems Calcified (1077); Material Perforation (2205); Obstruction of Flow (2423)

Patient Problems Calcium Deposits/Calcification (1758); Endocarditis (1834); Heart Failure (2206); Hemolytic Anemia (2279)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On an unknown date in 2012, a 27mm trifecta was implanted.On (b)(6) 2018, it was observed from echo that there were structural valve degeneration due to calcification.The peak gradient was 56mmhg, with ejection fraction of 40 - 45% and lv over 6cm.The patient experienced several heart failure episodes and hemolytic anemia last year.On (b)(6) 2020, the device was explanted.The device was replaced with another aortic valve.During the aortic valve replacement operation, it was observed that the non-coronary and left coronary cusps were fused in a closed position, and there was a hole in the right coronary cusp with degenerative changed.The trifecta valve was explanted and replaced with a 25mm on-x valve.This was suspected due to chronic endocarditis and old abscess in the right coronary cusp.

Manufacturer Narrative

Additional information for d10, g4, g7, h2, h3, h6, and h10.Explant was reported due to calcification.The investigation found that all three leaflets were fibrotically thickened, contained tears, and had calcifications.The calcifications immobilized the leaflets.There was fibrous pannus ingrowth on the inflow surface of leaflets 1 and 2 and on the outflow of leaflet 1.No inflammation was present.The cause of the tears could not be conclusively determined; however, all of the tears were associated with calcifications.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 10118322
• MDR Text Key: 193946158
• Report Number: 3008452825-2020-00266
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF-27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR