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

Model Number TFGT-23A

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

Patient Problems Atrial Fibrillation (1729); Infarction, Cerebral (1771); Death (1802); Pleural Effusion (2010); Sepsis (2067)

Event Date 04/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2017, an aortic valve replacement was performed and this 23 mm sjm trifecta gt valve was implanted.On (b)(6) 2017, chest x-ray showed pleural effusion in the right hemithorax and a thoracentesis was performed with 750ml of sanguineous fluid aspirated.On (b)(6) 2017, the patient developed asymptomatic controlled atrial fibrillation and was started on anti-coagulation with metoprolol for rate control.The patient was discharged and the valve remains implanted.(b)(6).

Event Description

On (b)(6) 2017, an aortic valve replacement was performed and this 23 mm sjm trifecta gt valve was implanted.On (b)(6) 2017, chest x-ray showed right pleural effusion and a thoracentesis was performed with 750ml of sanguineous fluid aspirated.On (b)(6) 2017, the patient developed asymptomatic controlled atrial fibrillation and was started on anti-coagulation and metoprolol for rate control.The patient was discharged.Follow up information reported that on (b)(6) 2017, the patient died from a large brain infarction while having sepsis.The cause of the brain infarction is unknown.(clinical study patient id: (b)(6)).

Event Description

On (b)(6) 2017, an aortic valve replacement was performed and this 23 mm sjm trifecta gt valve was implanted.On (b)(6) 2017, chest x-ray showed right pleural effusion and a thoracentesis was performed with 750ml of sanguineous fluid aspirated.On (b)(6) 2017, the patient developed asymptomatic controlled atrial fibrillation and was started on anti-coagulation and metoprolol for rate control.The patient was discharged.On (b)(6) 2017, the patient was admitted with a high fever.The original focus was thought to be urology infection, endocarditis and/or neuro infection; however, the infection focus was not found.In the analysis results that arrived on (b)(6) 2017, dna of e.Coli, k.Pneumoniae and s.Aureus were positive in blood.At arrival to the infection unit the patient was hemodynamically stable, but no verbal contact was achieved.Anticoagulant was added to treatment, amiodarone infusion was started to recover sinus rhythm.Regardless of the treatment the patient died on (b)(6) 2017 due to a large brain infarction (embolism).The cause of the brain infarction is unknown.(clinical study patient id: (b)(6)).

• 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: 6575035
• MDR Text Key: 75432930
• Report Number: 3008452825-2017-00108
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 10/23/2017

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: 11/15/2018
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 5757005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: 10/05/2017; 10/12/2017
• Supplement Dates FDA Received: 10/06/2017; 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: 74 YR