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); Material Split, Cut or Torn (4008)

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

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2018, a 21mm trifecta gt valve was implanted.On an unknown date, the patient presented with aortic insufficiency; it was reported that the patient "heard a pop and then was short of breath." on (b)(6) 2021, the trifecta gt valve was explanted and upon explant, a torn leaflet was observed.A non-abbott valve was successfully implanted.The patient was reported to be recovering.No additional information is available.

Manufacturer Narrative

Additional information sections: d9, h3, h6, h10.Explant was reported due to aortic insufficiency and "the patient heard a pop and then was short of breath".The investigation found that all three leaflets were torn.Leaflet 1 had focal thin fibrous pannus on the inflow surface.Leaflet 1 and leaflet 2 had a thin layer of fibrin.There was no acute inflammation or significant calcifications.X-ray inspection of the returned valve demonstrated deformation of stent posts 2 and 3, which appeared bent outward.As this was an explanted valve it is not possible to confirm when the observed deformation occurred, or if the stent deformations contributed to the severity of the leaflet damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.This review was inclusive of the final inspection videos.The manufacturing inspections and the functional testing demonstrated that at the time the valve was manufactured the valve had normal leaflet coaptation and function without evidence of stent deformation.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 demonstrate loss of collagen at the tear site, which could have contributed to the formation of the tear.The fibrous pannus ingrowth noted 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.There was also evidence of two outwardly bent stent post in association with the torn leaflets.An outward bent stent post may result in a localized increase in leaflet stress which may potentially contribute to the observed non-calcific leaflet tear.However, since it is unknown whether the stent deformation occurred before or after the valve explant, the cause of the torn leaflets cannot 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; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): 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
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12277174
• MDR Text Key: 265055729
• Report Number: 3014918977-2021-00037
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: BR00014014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female