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

Model Number TFGT-21A

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Heart Failure (2206); No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

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) 2017, a 21mm trifecta gt valve was implanted in the patient's aortic position.The patient complained of dyspnea on (b)(6) 2020, and was hospitalized on (b)(6) 2020 to control the heart failure.The valve damage was suspected in echocardiogram performed on (b)(6) which led to a re-do avr on (b)(6) 2020.The trifecta gt valve was explanted, replaced with a 21mm inspiris resilia aortic valve(manufacturer: edwards lifesciences).Upon explant, the valve was torn largely from the lcc and the ncc stent post, to the lcc side.The surgeon attributed the issue to the valve; he often heard of problems of tears occurring on the trifecta gt valves.The sales rep.Thought that the issue was acute aortic regurgitation that often occur on the trifecta gt valves.

Manufacturer Narrative

The reported event of dyspnea, heart failure, and a torn cusp could not be confirmed.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.

• Brand Name: TRIFECTA GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); 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: 10528680
• MDR Text Key: 206784922
• Report Number: 3008452825-2020-00472
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6062618
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR