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

Model Number TFGT-21A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Pneumonia (2011)

Event Date 06/16/2020

Event Type  Death  

Manufacturer Narrative

An event of patient death after the device implant procedure due to bleeding attributed to a thrombus was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020 the patient was admitted to the hospital for an elective aortic valve replacement due to severe aortic stenosis and a very heavily calcified aortic valve.On (b)(6) 2020 the procedure took place and a 23 mm trifecta gt valve was used.During the implant procedure, the physician decalcified the valve and implanted the 23 mm valve.The 23 mm valve was too large so it was replaced with a 21 mm trifecta gt valve.While coming off of bypass they were unable to recover left ventricular (lv) motion, so a coronary artery bypass grafting (cabg) was performed.During cabg, the patient went into cardiopulmonary arrest (cpa) and was moved to extracorporeal membrane oxygenation (ecmo) using central lines and protamine hemostasis and 3 drains to mediastinum.The patient was then draped and the operation finished.The patient was transferred to the intensive care unit (icu) where they had ongoing bleeding from the left atrium attributed to the thrombus.Removal of the thrombus would require cardiopulmonary bypass (cpb) and the patient wouldn't survive the further surgery, so the treatment was withdrawn.The patient passed away the following day on (b)(6) 2020.The cause of death was ascribed to a large clot in the patients left atrium.The physician didn't allege that the event was caused by the abbott device.

Manufacturer Narrative

Correction: - date of death.

• Brand Name: TRIFECTA GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); 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: 11061339
• MDR Text Key: 223354085
• Report Number: 3008452825-2020-00717
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• 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: 12/29/2020

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: 09/23/2023
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 7192938
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 74 YR