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

Model Number TFGT-25A

Device Problem Insufficient Information (3190)

Patient Problems Infarction, Cerebral (1771); Death (1802)

Event Date 09/28/2018

Event Type  Death  

Event Description

On (b)(6) 2017, a 25mm trifecta gt valve was implanted.On (b)(6) 2018, while on holiday in another country, the patient had a brain infarction secondary to an embolus and was treated with thrombolysis therapy.The patient had a repeat brain infarction that ultimately resulted in brain death.The patient was declared an organ donor, and after donation, an autopsy was performed.Post-mortem, it was discovered that the patient had a low-grade differentiated malignant tumor of the appendix.The impact of the prosthetic valve on the embolic event is unknown and the findings from the heart at autopsy have been requested.(clinical study patient id:(b)(6)).

Manufacturer Narrative

An event of an embolus and patient death were 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) 2017, a 25mm trifecta gt valve was implanted.On (b)(6) 2018, while on holiday in another country, the patient had a brain infarction secondary to an embolus and was treated with thrombolysis therapy.The patient had a repeat brain infarction that ultimately resulted in brain death.The patient was declared an organ donor, and after donation an autopsy was performed.Post-mortem it was discovered that the patient had a low-grade differentiated malignant tumor of the appendix.The impact of the prosthetic valve on the embolic event is unknown and no autopsy was performed.The patient had a history of coronary artery disease and diabetes.(b)(4).

• 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 (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8177026
• MDR Text Key: 130763131
• Report Number: 3008452825-2018-00420
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: 05415067018236
• Combination Product (y/n): N
• Reporter Country Code: EN
• 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,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: TFGT-25A
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 5919973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 80