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

Catalog Number	TFGT-21A
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017, a 21mm trifecta gt valve was successfully implanted.In (b)(6)2023, the patient visited a nearby facility due to difficulty breathing.On (b)(6) 2023, tear was observed in the stent area between the right coronary cusp and the non-coronary cusp.Severe aortic regurgitation was observed.On (b)(6) 2024, another procedure was performed.The trifecta was explanted and a 19mm valve was implanted.The patient is reported to be under rehabilitation.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant due to leaflet tear and severe aortic regurgitation was reported.The investigation found that leaflet 1 and leaflet 3 were torn.There was no acute inflammation or significant calcifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did not demonstrate loss of collagen at the tear site.The cause of the leaflet tear 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: 18711817
• Report Number: 2135147-2024-00677
• Device Sequence Number: 7186904
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: (01)05415067018212(17)181027(10)5730968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 04/15/2024

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: 10/27/2018
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5730968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2016
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female