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

Model Number TFGT-21A

Device Problem Missing Information (4053)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

On an unknown date, a 21m trifecta valve was implanted and on an unknown date in 2019, it was explanted.The user has not provided details on the implant duration or the factors leading to explant.Patient co-morbidities are unknown and beyond the explant surgery there is no information on patient status.Additional information has been requested.

Event Description

On (b)(6) 2016, a 21m trifecta gt valve was implanted.On (b)(6) 2019, the valve was explanted due to aortic insufficiency from a loosened stent.The device was replaced with a 19mm edwards magna ease valve.Additional information has been requested.

Manufacturer Narrative

The valve was reportedly explanted due to aortic insufficiency due to a leaflet "loosening from the stent".The middle section of the base was torn away from the stent, and a small section of the metal stent was exposed at the tear site.There was circumferential fibrous pannus ingrowth on the inflow surface, narrowing the inflow diameter.Fibrous pannus ingrowth was also noted on the outflow surface of leaflet 2 and straddling commissure of leaflets 2 and 3 at the end of stent post 3.No inflammation or significant calcifications were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.This was inclusive of a review of the manufacturing videos, which contained no evidence of anomalies during functional inspection.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.Non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress, but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did not demonstrate loss of collagen at the tear site and the cause of the leaflet tear could not be conclusively determined; however, the host to device reaction (pannus formation), along with the selected valve size (21 mm) larger than the replacement valve (19 mm), are possible evidence of oversizing.This, along with the pannus noted on the inflow surface, had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

Event Description

On (b)(6) 2016, a 21m trifecta gt valve was implanted.On (b)(6) 2019, the valve was explanted due to aortic insufficiency resulting from a tear observed near the stent post.The device was replaced with a 19mm edwards magna ease valve and no patient consequences were reported.

• 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 1897- 4050; CS 1897-4050
• MDR Report Key: 8491906
• MDR Text Key: 141210292
• Report Number: 3008452825-2019-00157
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (y/n): N
• PMA/PMN Number: P100029/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2017
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5328431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention