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

Model Number TFGT-23A

Device Problem Biocompatibility (2886)

Patient Problem Infarction, Cerebral (1771)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 23 mm trifecta gt valve was implanted in the patient's aortic position.A mass of vegetation formed on the valve and cerebral infarction occurred on the patient.An emergency surgery was performed on (b)(6) 2020, and the trifecta gt valve was explanted, replaced with a 23 mm inspiris resilia aortic valve (manufacturer: (b)(4)).There was no adverse consequence to the patient.

Manufacturer Narrative

Corrected information:d3.Additional information: d10, g2, g4,g7, h2, h3, h6 & h10.Explant was reported due to vegetation and cerebral infarction.The investigation found probable endocarditis (clinical correlation would be required) with treatment effects.Vegetations were found on the inflow and outflow surface of all three leaflets.Intact and degenerating acute and chronic inflammatory cells, consistent with a treatment effect, were present.Focal disruption of cusp tissue by the vegetation was present in leaflet 2.A micro-calcification was present in a detached piece of thrombus from leaflet 1.Grams stains were negative for organisms.All three leaflets were fibrotically thickened.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the vegetation could not be conclusively determined.

• Brand Name: TRIFECTA GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte MN 31310 -260; BR 31310-260
• MDR Report Key: 10397002
• MDR Text Key: 202578400
• Report Number: 3007113487-2020-00024
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: BR00021328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 67 YR