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

Model Number	TFGT-A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, a 19mm trifecta valve was implanted into the patient.On (b)(6) 2023, it was noted by echocardiogram that the patient had moderate to severe aortic regurgitation.The patient reported dyspnea.The physician suspects a tear.Diuretics were administered.The patient is reported to be hospitalized and recovering.
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 moderate to severe aortic regurgitation and dyspnea was reported.It was also reported that a suspects a tear was suspected.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.A transthoracic echocardiography (tte) images with measurement of aortic valve mean transvalvular gradient of 16.6 mmhg were provided by the field.On long-axis of the aortic valve two leaflets were visualized with normal opening and leaflet motion.There was no evidence for a leaflet tear, however with two-dimensional tte it is not possible to clearly visualize all three leaflets.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 LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16868279
• Report Number: 2135147-2023-01931
• Device Sequence Number: 20285142
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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 Model Number: TFGT-A
• Device Catalogue Number: TFGT-19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 89 YR
• Patient Sex: Female