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

Catalog Number	TFGT-29A
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020, a 29mm trifecta gt valve was successfully implanted.In (b)(6) 2022, the patient began having shortness of breath.The patient's bnp was elevated, suggesting heart failure.On (b)(6) 2023, a transthoracic echocardiogram (tte) showed severe bioprosthetic valvular regurgitation with holodiastolic flow reversal in the descending aorta.The mean gradient was 18mmhg.On (b)(6) 2023, a transesophageal echocardiogram (tee) showed that the right coronary cusp of the trifecta valve was flailed and prolapsing into the left ventricular outflow tract (lvot).There was severe, eccentric, posteriorly directed aortic regurgitation.On (b)(6) 2023, the valve was explanted and replaced with a 29mm epic supra valve.The physician noted that one of the leaflets was torn away from the struts.A pathology report of the trifecta valve showed two valve leaflets were ragged and disrupted.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of insufficiency due to a leaflet tears and explant of the valve was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.Information from the field indicated that the trifecta valve was torn away from the struts.However, based on the information received, the reported leaflet tear is consistent with structural valve deterioration (svd), specifically non-calcific leaflet tear, 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.However, a tee imaging result was provided which indicated a leaflet tear but no stenosis, thereby ruling out another type of svd, fibrocalcific svd.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 also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 19394448
• Report Number: 2135147-2024-02389
• Device Sequence Number: 7744116
• Product Code: LWR
• UDI-Device Identifier: 05415067018250
• UDI-Public: (01)05415067018250(17)220612(10)6575900
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 06/12/2022
• Device Catalogue Number: TFGT-29A
• Device Lot Number: 6575900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2018
• 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: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White