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

Model Number TFGT-23A

Device Problems Backflow (1064); Incomplete Coaptation (2507); Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020 the patient presented to the hospital with dyspnea.A trifecta gt valve implanted on (b)(6) 2018 was explanted due to echocardiography revealing severe aortic insufficiency due to leaflet tear near the cusp.The valve was replaced by a livanova perceval s to resolve the event.The patient is currently stable.

Manufacturer Narrative

Additional information: g4, h2, and h10 correction: d4.

Manufacturer Narrative

Explant was reported due to aortic insufficiency and a leaflet tear.The investigation found that leaflets 2 and 3 were torn.There was fibrous pannus ingrowth on the inflow surface which extended onto all three leaflets and on the outflow surface of leaflet 1.No acute inflammation or significant calcifications were present.Stent post 1 appeared twisted and stent post 3 appeared bent.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 of 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, histological evaluation did demonstrate loss of collagen at one tear site which could have contributed to the tear formation.In addition, the pannus noted on the valve could have induced increased stress on adjacent leaflets and created an unbalanced stress relief distribution between all leaflets during coaptation, which may lead to leaflet tears and reduced durability two deformed stent posts were also found.A bent stent post may result in a localized increase in leaflet stress which may potentially contribute to the observed non-calcific leaflet tear.However, it is unknown whether the observed stent deformation occurred before or after valve explant, and the exact cause of the leaflet tear could not be conclusively determined.

Manufacturer Narrative

Explant was reported due to aortic insufficiency and a leaflet tear.The investigation found that leaflets 2 and 3 were torn.There was fibrous pannus ingrowth on the inflow surface which extended onto all three leaflets and on the outflow surface of leaflet 1.No acute inflammation or significant calcifications were present.Stent post 1 appeared twisted and stent post 3 appeared bent.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 of 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, histological evaluation did not demonstrate loss of collagen at the tear site and the cause of the leaflet tear could not be conclusively determined.The pannus noted on the valve could have induced increased stress on adjacent leaflets and created an unbalanced stress relief distribution between all leaflets during coaptation, which may lead to leaflet tears and reduced durability in addition, two deformed stent posts were also found.A bent stent post may result in a localized increase in leaflet stress which may potentially contribute to the observed non-calcific leaflet tear.

• Brand Name: TRIFECTA GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); 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: 11015483
• MDR Text Key: 221724326
• Report Number: 3008452825-2020-00703
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• 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,Followup,Followup
• Report Date: 03/29/2021

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: 09/04/2021
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6145196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 03/04/2021; 03/24/2021
• Supplement Dates FDA Received: 12/17/2020; 03/09/2021; 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention