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

Catalog Number	TFGT-21A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A medwatch email was received on 30 august 2023, reporting the incident with e100-25m-00 and tfgt-21a.It was reported that a 25mm stented porcine,mit,epic 25mm-00 and 21mm trifecta gt final package - wr was implanted in a patient on (b)(6) 2018.On an unknown date and year, the patient was hospitalized requiring increase in medication due to heart failure.A transesophageal echocardiogram (tee) results showed aortic valve: bioprosthetic aortic valve present.Leaflets are mobile, there was moderate transvalve aortic regurgitation.The di is 0.41.At is 92ms.The mg is 28mmh mitral valve well seated, no stenosis or regurgitation.Tee reveals normal right ventricular/left ventricular function and normal wash out jet.No paravalvular leak (pvl).The bioprosthetic trifecta aortic valve has mild degeneration changes with no stenosis, however has moderate aortic regurgitation and also patient prosthesis present.Need to switch to coumadin due to valvular atrial fibrillation (af), with local cardiologist.Potential mismatch of the device.Patient status is unknown reference report: mw5120624.
Additional Manufacturer Narrative
An event of moderate aortic regurgitation and valvular atrial fibrillation (af) was reported.It was also reported that the trifecta aortic valve had mild degeneration changes with no stenosis.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.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 as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 17789640
• Report Number: 2135147-2023-04113
• Device Sequence Number: 7472794
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (Y/N): N
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2023

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: 03/13/2019
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5928344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• 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: Hospitalization
• Patient Sex: Unknown