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

Catalog Number	TFGT-23A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
User facility medwatch report mw5156222 received that states "on (b)(6) 2023 saw cardiologist for recent hospitalization and finding of abnormal bioprosthetic valve.Status post 23 mm triecta bioprosthetic valve placed on (b)(6) 2018 at (b)(6) by (b)(6).Received notification letter july 2023 about trifecta valve being called off the market.Had an echo (b)(6) 2023 and cardiology visit on (b)(6) 2023.Readings from echo showed from (b)(6)/2023 bioprosthetic valve gradient has increased from baseline.The valve leaflets are abnormally thickened.The gradient has increased to 37 mmhg with a peak velocity of 3.7 m/s.Symptoms documented progressive exertional dyspnea and fatigue.Nyla class ii and worsening.New diagnoses of bioprosthetic structural valve degeneration.Valve appears abnormal, gradients are significantly elevated.I was referred back to (b)(6) for redo surgical consult.On (b)(6) 2024 i had an echo transthoracic impressions aortic valve prostheses systolic mean doppler gradient 43mmhg, effective orifice area 0.94cm.Comprehensive office visit with (b)(6) on (b)(6) 2024 where redo aortic valve replacement was agreed upon.Surgery occurred on (b)(6) 2024 with a dual pace pacemaker placed on (b)(6) 2024.Hospital stay was 7 days in the surgical icu then transferred to step down after pacemaker placed on (b)(6) 2024.Discharge (b)(6) 2024.These surgeries occurred at (b)(6)." it was reported that in 2018, a 23mm trifecta valve was implanted during an aortic valve replacement.In 2023, the patient was seen by a cardiologist for recent hospitalization and abnormal finding on valve.The patient had an echocardiogram in 2023 which showed that the valve gradient had increased from baseline and that the valve leaflets were abnormally thickened.The gradient had increased to 37mmhg with a peak velocity of 2.7m/s.Patient had symptoms of progressive exertional dyspnea, fatigue, and heart failure.There was structural valve degeneration present.In 2024, the patient had a transthoracic echocardiogram (tte) which showed a mean doppler gradient of 43mmhg, effective orifice area of 0.94cm^2.In 2024, the valve was explanted and replaced, and a pacemaker was also implanted.The patient remained in the surgical intensive care unit (icu) in the hospital for 7 days, and then was transferred after the pacemaker was placed.The patient was then discharged.
Event or Problem Description
User facility medwatch report mw5156222 received that states "on (b)(6) 2023 saw cardiologist for recent hospitalization and finding of abnormal bioprosthetic valve.Status post 23 mm triecta bioprosthetic valve placed on (b)(6) 2018 at (b)(6) by (b)(6).Received notification letter july 2023 about trifecta valve being called off the market.Had an echo (b)(6) 2023 and cardiology visit on (b)(6) 2023.Readings from echo showed from (b)(6) 2023 bioprosthetic valve gradient has increased from baseline.The valve leaflets are abnormally thickened.The gradient has increased to 37 mmhg with a peak velocity of 3.7 m/s.Symptoms documented progressive exertional dyspnea and fatigue.Nyla class ii and worsening.New diagnoses of bioprosthetic structural valve degeneration.Valve appears abnormal, gradients are significantly elevated.I was referred back to (b)(6) for redo surgical consult.On (b)(6) 2024 i had an echo transthoracic impressions aortic valve prostheses systolic mean doppler gradient 43mmhg, effective orifice area 0.94cm.Comprehensive office visit with (b)(6) on (b)(6) 2024 where redo aortic valve replacement was agreed upon.Surgery occurred on (b)(6) 2024 with a dual pace pacemaker placed on (b)(6) 2024.Hospital stay was 7 days in the surgical icu then transferred to step down after pacemaker placed on (b)(6) 2024.Discharge (b)(6) 2024.These surgeries occurred at (b)(6)." it was reported that on (b)(6) 2018, a 23mm trifecta valve was implanted during an aortic valve replacement.In 2023, the patient was seen by a cardiologist for recent hospitalization and abnormal finding on valve.The patient had an echocardiogram in 2023 which showed that the valve gradient had increased from baseline and that the valve leaflets were abnormally thickened.The gradient had increased to 37mmhg with a peak velocity of 2.7m/s.Patient had symptoms of progressive exertional dyspnea, fatigue, and heart failure.There was structural valve degeneration present.In 2024, the patient had a transthoracic echocardiogram (tte) which showed a mean doppler gradient of 43mmhg, effective orifice area of 0.94cm^2.In 2024, the valve was explanted and replaced, and a pacemaker was also implanted.The patient remained in the surgical intensive care unit (icu) in the hospital for 7 days, and then was transferred after the pacemaker was placed.The patient was then discharged.
Additional Manufacturer Narrative
An event of recent hospitalization and abnormal finding on a valve was reported.Information from the field indicated that the valve gradient had increased from baseline and that the valve leaflets were abnormally thickened.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.However, based on the information received, the reported stenosis is consistent with structural valve deterioration (svd), specifically fibro-calcific svd (fcsvd), which is a well-known complication of tissue heart valve replacement surgery.A variety of factors may contribute to svd, including patient, biological, and implant related factors.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.Biological factors which can result in tissue degeneration such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.) or thinning of the prosthetic leaflet tissue (predisposing to leaflet tears) also could not be confirmed as the valve was not returned for histopathological examination.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: TRIFECTA¿ GT VALVE
• Common Device Name: 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: 19883021
• Report Number: 2135147-2024-03708
• Device Sequence Number: 14502615
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)220513(10)6479927
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2022
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6479927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: White