MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A

Device Problem Torn Material (3024)

Patient Problems Aortic Insufficiency (1715); Endocarditis (1834)

Event Date 04/26/2018

Event Type  Injury  

Event Description

On (b)(6) 2013, an aortic valve replacement was performed and a 23mm trifecta valve was implanted in the patient's aortic position.Concomitant procedures included a mitral valvuloplasty with a sequin semi-rigid ring, tricuspid annuloplasty with a tailor annuloplasty band and maze procedure were performed.On (b)(6) 2018, the trifecta valve was explanted due to prosthetic valve endocarditis and transvalvular leakage.Upon explant of this valve, a tear was observed from the upper commissure between non-coronary cusp (ncc) and right coronary cusp (rcc) toward the ncc.During explant, the cusps and the sewing cuff were damaged/fractured by medical instruments.A 21mm carpentier-edwards perimount magna ease aortic heart valve was implanted as the replacement.The mitral annuloplasty ring remain implanted as there was no evidence of infection at the mitral valve.The patient is reported to be stable postoperatively.

Event Description

On (b)(6) 2013, an aortic valve replacement was performed and a 23mm trifecta valve was implanted in the patient's aortic position.Simultaneously, mitral valvuloplasty, tricuspid annuloplasty and maze procedure were performed.A seguin semi-rigid ring was reported to be implanted in the mitral position and a tailor annuloplasty ring/band in the tricuspid position.On (b)(6) 2018, the trifecta valve was explanted due to prosthetic valve endocarditis and transvalvular leakage.Upon explant of this valve, a tear was observed from the upper commissure between non-coronary cusp (ncc) and right coronary cusp (rcc) toward the ncc.During explant, the cusps and the sewing cuff were damaged/fractured by medical instruments.A 21mm carpentier-edwards perimount magna ease aortic heart valve was implanted as the replacement.As any infection did not extend to the mitral position, the mitral annuloplasty ring remain implanted in the patient.The patient is reported to be stable postoperatively.

Manufacturer Narrative

The reported event of endocarditis and a torn leaflet was confirmed.Transvalvular leakage was also reported.Morphological and histopathological examination revealed the valve contained infective endocarditis.Active and healing vegetations were present in all three leaflets, with focal gram positive cocci on leaflet 2.All three leaflets were fibrotically thickened and contained fibrous pannus ingrowth on their inflow surface, narrowing the inflow diameter.Microcalcifications were found in leaflets 1 and 3.All three leaflets contained tears.Information from the field indicated the leaflets were damaged during explant, making it difficult to determine how torn the leaflets were prior to extraction.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the infection remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 7539090
• MDR Text Key: 109092537
• Report Number: 3001883144-2018-00043
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2015
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4274098
• Other Device ID Number: 05414734052030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR