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

Model Number TFGT-21A

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

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

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, 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.An abbott sizer was used in the surgery.On an unknown date the patient suddenly experienced shortness of breath during exertion, and was diagnosed as aortic regurgitation.A re-do avr was performed, and the trifecta gt valve was explanted, replaced with a carpentier-edwards perimount magna ease aortic heart valve(manufacturer: edwards lifesciences).The patient is stable.

Manufacturer Narrative

The reported tear was confirmed.Leaflet 1 was torn from stent post 2, and leaflet 3 contained a small tear at stent post 3.Qualitative x-ray examination revealed stent posts 1 and 3 were bent.All three leaflets were fibrotically thickened and leaflet 3 contained a fold/retraction.Focal tissue was noted on the outflow surface of all three stent posts.No inflammation or significant calcifications were present.The device history record was reviewed to ensure 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, including no evidence of stent post deformation.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, 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 tissue noted on the outflow surface was possible evidence of interaction with the patient's aortic wall, which would have 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.If the noted stent post deformation existed prior to explant, it would exacerbate this redistribution.

• 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: 10671076
• MDR Text Key: 211254935
• Report Number: 3008452825-2020-00555
• Device Sequence Number: 1
• Product Code: LWR
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: TFGT-21A
• Device Lot Number: 5775887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR