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

Model Number TFGT-23A

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

An event of a thrombus 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.

Event Description

On (b)(6) 2018, an aortic valve replacement (avr) and mitral valvuloplasty (mvp) were performed and this 23 mm trifecta gt valve was implanted in the patient's aortic position and a contour 3d ring was used for the mvp.On (b)(6) 2018, an echocardiogram was performed and prosthetic valve thrombosis was suspected.On (b)(6) 2018, prosthetic valve thrombosis was confirmed via transthoracic echocardiography.On (b)(6) 2018, a redo thoracotomy was performed for recurrent mitral regurgitation (mr).Upon surgical intervention, thrombus was significantly adhered to the non-coronary cusp (ncc) of the 23 mm trifecta gt valve.The adhered thrombus was completely removed from the valve and the 3d ring remained implanted with additional stitches inserted around the ring.The procedure was successfully completed with no issues.The trifecta gt remains implanted and the patient is being monitored.Patient specific information of birthdate and weight are not available for this complaint.No additional information is expected.

• Brand Name: TRIFECTA¿ GT 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
• Manufacturer (Section G): 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
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7430017
• MDR Text Key: 105440802
• Report Number: 3008452825-2018-00122
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029/S021
• 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
• Report Date: 04/13/2018

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: 06/14/2021
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6052533
• Other Device ID Number: 05415067018229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• 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: 81 YR