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

Model Number TF-19A

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 12/09/2017

Event Type  Injury  

Event Description

On (b)(6) 2014, a double valve replacement was performed.An unknown valve was implanted in the mitral position and this 19 mm trifecta valve was implanted in the aortic position with non-everting mattress sutures.The dedicated sizer set (model: tf2000) was used to size the patient's annulus.On (b)(6) 2017, the patient presented to the hospital due to chest pain.An echocardiogram revealed severe aortic regurgitation (ar) which required an emergency surgical intervention.The trifecta valve was explanted and a 19 mm regent mechanical heart valve (model number: 19agfn-756, sn: (b)(4)) was implanted.Upon explant of the trifecta valve, a tear was observed at the commissure between a right coronary cusp (rcc) and non-coronary cusp (ncc), towards the ncc along the stent post.The surgeon indicated the patient does not have a medical history which would accelerate structural valve deterioration of the valve.The patient specific information of birthdate and weight are not available.The valve was discarded at the hospital.

Manufacturer Narrative

An event of tear was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 7171547
• MDR Text Key: 96608073
• Report Number: 3001883144-2018-00002
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4275489
• Other Device ID Number: 05414734052016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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; Required Intervention
• Patient Age: 75 YR