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 Code	Mitral Valve Stenosis (1965)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported severe aortic stenosis after 6 years of trifecta valve implant.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 stenosis such 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.The exact cause of the reported incident could not be conclusively determined.The reported surgical intervention was a result of valve-in-valve implant.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2017, a 23mm trifecta gt valve was implanted in the patient.On (b)(6) 2024, the patient presented with severe aortic stenosis, and a valve in valve procedure performed with a 23mm navitor valve and mitral valve replacement performed with a 23mm non-abbott valve.On (b)(6) 2024, patient had severe stenosis, and a valve in valve procedure performed with a 29mm non abbott valve.The patient was reported stable.

• 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: 20487083
• Report Number: 2135147-2024-05183
• Device Sequence Number: 11642675
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)190116(10)5841708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 01/16/2019
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 5841708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female