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

Model Number TFGT-21A

Device Problems Backflow (1064); Calcified (1077); Obstruction of Flow (2423); Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

On (b)(6) 2018, an avr was conducted and a 21mm trifecta gt valve was implanted with the non-everting mattress suture technique using pledgets in the patient's aortic position, in which severe calcification was observed on the annulus.An abbott sizer was used in the surgery.While the patient was being followed up, there were symptoms of severe aortic stenosis (as), moderate aortic regurgitation (ar), and signs of infection.The surgeon judged it as structural valve deterioration (svd), and a re-do avr was performed on (b)(6) 2021.The trifecta gt valve was explanted, replaced with a 21mm inspiris resilia aortic valve (manufacturer: edwards lifesciences).Upon explant, there was pannus formation between the aorta wall and the trifecta gt valve, which could've impaired the mobility of the valve leaflets.Sclerosis on the leaflets was also observed.There was a vegetation-like object adhered to the leaflet part which was suspected to be due to infective endocarditis (ie), but the ie was likely to have occurred after occurrence of svd.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is in stable condition postoperatively.

Manufacturer Narrative

Additional information: g3, h2, h3, h6, h10 explant was reported due to stenosis, regurgitation, signs of infection, and structural valve deterioration.The investigation found that there was amorphous, eosinophilic material on the inflow surface of leaflets 1 and 3, and a con kossa stain was negative for calcium.This material could not be identified and most strongly resembled surgical material such as bioglue or a hemostatic substance, but the exact material was uncertain.It was not consistent with infective vegetations or calcification.All three leaflets contained pannus on the outflow surface and leaflet 2 contained pannus on the inflow surface.All three leaflets were torn and had fibrous thickening.No acute inflammation or significant calcifications were present, and gram stains were negative for organisms.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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.A 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, the tears were not included in the histological sections.The cause of the tear could not be conclusively determined; however, the fibrous pannus ingrowth noted on the inflow and outflow, along with the unidentified material 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.

Manufacturer Narrative

Explant was reported due to stenosis, regurgitation, signs of infection, and structural valve deterioration.The investigation found that there was amorphous, eosinophilic material on the inflow surface of leaflets 1 and 3, and a con kossa stain was negative for calcium.This material could not be identified and most strongly resembled surgical material such as bioglue or a hemostatic substance, but the exact material was uncertain.It was not consistent with infective vegetations or calcification.All three leaflets contained pannus on the outflow surface and leaflet 2 contained pannus on the inflow surface.All three leaflets were torn and had fibrous thickening.No acute inflammation, stent deformation, or significant calcifications were present, and gram stains were negative for organisms.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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.A 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, the tears were not included in the histological sections.The cause of the tear could not be conclusively determined; however, the fibrous pannus ingrowth noted on the inflow and outflow, along with the unidentified material 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.

• 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: 11792013
• MDR Text Key: 250810047
• Report Number: 3008452825-2021-00270
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6373305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/03/2021; 08/18/2021
• Supplement Dates FDA Received: 06/08/2021; 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR