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

Model Number TFGT-19A

Device Problem Obstruction of Flow (2423)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing reference number 3001883144-2021-00098.Information received on 6 july 2021 reported that a 19mm trifecta gt valve was also implanted on (b)(6) 2017.On an unknown date, aortic stenosis was observed and the valve was explanted.A non-abbott device was successfully implanted.The patient status was reported as unknown.Additional information has been requested and is pending.

Manufacturer Narrative

An event of explant of a trifecta gt valve due to stenosis was reported.A more comprehensive assessment could not be performed as 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturing reference number 3001883144-2021-00098.Information received on 6 july 2021 reported that a 19mm trifecta gt valve was also implanted on (b)(6) 2017.On an unknown date, aortic stenosis was observed and on (b)(6) 2021, the valve was explanted.A non-abbott device was successfully implanted.The patient status was reported as unknown.

• 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 01897 -405; CS 01897-4050
• MDR Report Key: 12280919
• MDR Text Key: 265169493
• Report Number: 3014918977-2021-00045
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• 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
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2018
• Device Model Number: TFGT-19A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 5655371
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR