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

Model Number	TFGT-27A
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Death (1802); Endocarditis (1834); Sepsis (2067)
Date of Event	10/20/2018
Type of Reportable Event	Death
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 8294936
• Report Number: 3001883144-2019-00010
• Device Sequence Number: 1587697
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: 05415067018243
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100029/S021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2019

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 04/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention