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

Model Number TFGT-21A

Device Problem Leak/Splash (1354)

Patient Problems Aortic Regurgitation (1716); Left Ventricular Dysfunction (1947); Pulmonary Edema (2020)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

An event of chest pain, pulmonary edema, transvalvular leakage and left ventricular systolic dysfunction was reported.The results of the investigation are inconclusive since the device remains implanted 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) 2016, a 21 mm trifecta gt valve was implanted without reported difficulty.On (b)(6) 2018, the patient presented with chest pain and pulmonary edema.An echocardiogram showed severe transvalvular aortic regurgitation and moderate left ventricular systolic dysfunction.A tavi procedure was performed on (b)(6) 2018 and a 23 mm edwards s3 valve was implanted within the trifecta gt valve.The patient is reported to be doing well.Additional information has been requested.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7923509
• MDR Text Key: 122222226
• Report Number: 3007113487-2018-00024
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 10/01/2018

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: 01/04/2018
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5361110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• 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): Hospitalization; Required Intervention