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

Model Number TFGT-27A

Device Problem Microbial Contamination of Device (2303)

Patient Problems Death (1802); Endocarditis (1834); Sepsis (2067)

Event Date 10/20/2018

Event Type  Death  

Event Description

A patient had a crmd high voltage device implanted on (b)(6) 2013 which was explanted on (b)(6) 2018 with information on replacement not made available.Then on (b)(6) 2017, the patient had a 33mm epic valve and 27mm trifecta gt implanted.On an unknown date, the patient was reported with endocarditis and diagnosed with sepsis.On (b)(6) 2018, the patient passed away.Additional information has been requested.

Manufacturer Narrative

An event of endocarditis, sepsis, and patient death 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 and the product met all defined manufacturing specifications at the time of release to commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A patient had a crmd high voltage device implanted on 18sept2013 which was explanted on (b)(6) 2018 with information on replacement not made available.Then on (b)(6) 2017, the patient had a 33mm epic valve and 27mm trifecta gt implanted.On an unknown date, the patient was reported with endocarditis and diagnosed with sepsis.On (b)(6) 2018, the patient passed away.No further information was provided.

• Brand Name: TRIFECTA¿ GT 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8294936
• MDR Text Key: 134690109
• Report Number: 3001883144-2019-00010
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: 05415067018243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: TFGT-27A
• Device Catalogue Number: TFGT-27A
• Device Lot Number: BR00010959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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