MAUDE Adverse Event Report: ABBOTT MEDICAL TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number TFGT-23A

Device Problems Perivalvular Leak (1457); Material Separation (1562); Central Regurgitation (4068)

Patient Problems Angina (1710); Dyspnea (1816); Pulmonary Edema (2020); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022, a 23mm sjm trifecta valve was successfully implanted.At the time of discharge, the patient was reportedly hemodynamically stable and symptomatically better.On (b)(6) 2023, the patient was presented with shortness of breath and chest pain.The leaflet was noted to be attached to the stent.Acute pulmonary oedema was confirmed under transthoracic echocardiogram (tte).Mild periprosthetic regurgitation was noted.There is at least moderate to severe valvular regurgitation.Medication was administered.On (b)(6) 2023, the trifecta valve was explanted.A replacement non-abbott device was implanted.The patient is reported to be stable and was discharged.

Manufacturer Narrative

An event of regurgitation, shortness of breath, and chest pain was reported in australia.It was also reported that the device was explanted in india about two weeks after this event.The device was received for investigation which found that leaflets 2 and 3 were torn.There was a think layer of fibrin on leaflets 2 and 3.A fold was present on the free edge of leaflet 3.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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 reveal any changes to the tissue at the tear site, and the cause of the tears could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code 4068 was removed.

Event Description

It was reported that on (b)(6) 2022, a 23mm sjm trifecta valve was successfully implanted in india.At the time of discharge, the patient was reportedly hemodynamically stable and symptomatically better.On (b)(6) 2023, the patient was presented to a hospital in australia with shortness of breath and chest pain.The leaflet attached to the post stent suture was noted to come out.Acute pulmonary oedema was confirmed under transthoracic echocardiogram (tte).Mild periprosthetic regurgitation was noted.There is at least moderate to severe valvular regurgitation.Medication was administered.On (b)(6) 2023, the patient traveled back to india and had the trifecta valve explanted.A replacement non-abbott device was implanted.The patient is reported to be stable and was discharged.

Event Description

It was reported that on 17 march 2022, a 23mm sjm trifecta gt valve was successfully implanted in a 75-year-old gentleman with severe aortic stenosis with heavily calcified non-coronary cusp in india.At the time of discharge, the patient was reportedly hemodynamically stable and symptomatically better.On (b)(6) 2023, the patient presented to a hospital in (b)(6) with a history of one-day of a sudden onset of shortness of breath and chest pain.Transthoracic echocardiography demonstrated at least moderate to severe aortic valve regurgitation.The patient was discharged on medical therapy on (b)(6) 2023 and was instructed to follow-up with a cardiologist/cardiothoracic surgeon in india.The patient returned to india and on (b)(6) 2023 underwent a redo aortic valve replacement using minimally invasive cardiac surgery (mics).The trifecta gt valve was explanted and replaced with a large sizer non-abbott aortic valve.The patient had an uneventful post-operative hospital course and discharge in stable condition on (b)(6) 2023.

Manufacturer Narrative

Explant of the trifecta gt valve was reported to be due to severe aortic valve regurgitation, a leaflet tear, shortness of breath, and chest pain.The device was received for investigation which found leaflet tears in leaflets 2 (4 mm tear) and leaflet 3 (2 mm and 13 mm tear) both in association with stent post 3.Additionally, leaflet 3 had fibrous thickening on the outflow surface.No acute inflammation or significant calcifications were present on histopathological examination.X-ray inspection of the returned valve demonstrated deformation of the stent which consisted of stent post 3 being bent outward.A review of the valve¿s device history record along with videos of the valve from the time of manufacturing confirmed that each manufacturing and inspection operation was completed in accordance with abbott specifications and procedures.The manufacturing inspections and the functional testing demonstrated that at the time the valve was manufactured the valve had normal leaflet coaptation and function with no 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.In this case there is evidence of an outward bent stent post in association with the torn leaflets, as well as evidence of fibrous thickening of the cusp associated with the longest observed leaflet tear (leaflet 3).An outward bent stent post may result in a localized increase in leaflet stress which when combined with fibrous thickening of the cusp may potentially contribute to the observed non-calcific leaflet tear.Based on this analysis most likely the non-calcific leaflet tear observed on leaflets 2 and 3 was due to implant related technical factors that resulted in an outward bent stent post, which over 20 months of implant in combination with fibrous thickening on leaflet 3 led to the observed leaflet tears.However, since it is unknown whether the stent deformation occurred before or after the valve explant, the cause of the torn leaflet cannot be conclusively determined.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18371859
• MDR Text Key: 331092368
• Report Number: 2135147-2023-05644
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)241011(10)7729493
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2024

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 Catalogue Number: TFGT-23A
• Device Lot Number: 7729493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/24/2024; 04/26/2024
• Supplement Dates FDA Received: 02/06/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 60 KG