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

Model Number TF-21A

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 01/18/2018

Event Type  Injury  

Event Description

A 21 mm trifecta valve was implanted in the aortic position, on (b)(6) 2014, during a double valve replacement due to aortic stenosis with regurgitation.A 27 mm epic valve was implanted in the mitral position due to mitral stenosis with regurgitation.In (b)(6) 2017, the patient presented at the hospital due to cardiac failure.A clinical examination was conducted and structural valve deterioration of the trifecta valve was confirmed.On (b)(6) 2018, re-do avr was performed and the trifecta valve was explanted.Upon explant of this valve, a tear was observed from the stent post shared with a left coronary cusp (lcc) and a right coronary cusp (rcc) toward the lcc side.Subsequently, a 19 mm carpentier-edwards perimount magna ease aortic heart valve was implanted.The patient was reported to be in stable condition postoperatively.Reportedly, the patient was treated with antibiotic due to infective endocarditis in 2006, then recovered after medication.There were no anomalies reported on the epic valve which remains implanted.During explant of the trifecta valve, damage was reported to the sewing cuff consistent with fracture.

Manufacturer Narrative

The reported event of a tear was confirmed.Morphological and histopathological examination found leaflets 1 and 3 were torn, and all three leaflets contained fibrous pannus ingrowth on their inflow surfaces.No acute inflammation or significant calcifications were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn leaflet tissue 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7277748
• MDR Text Key: 100303469
• Report Number: 3001883144-2018-00024
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/07/2016
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4652012
• Other Device ID Number: 05414734052023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 77 YR
• Patient Weight: 47