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

Model Number	TFGT-A
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient-Device Incompatibility (2682); Material Deformation (2976); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2018, a 19mm trifecta gt was implanted.On an unknown date in (b)(6) 2022, the patient reported that they had shortness of breath.On an unknown date of (b)(6) 2022, a transesophageal echocardiogram (tee) and transthoracic echocardiogram (tte) were done and severe aortic regurgitation was discovered.On (b)(6) 2022, the device was then explanted and replaced with a 17mm non-abbott device.Upon explanation, it was noted that there was pannus, incomplete coaptation, inflexible leaflets, and the left coronary cusp leaflet was stretched.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of shortness of breath and explant due to severe aortic regurgitation was reported.It was also reported that there was pannus, incomplete coaptation, inflexible leaflets, and the left coronary cusp leaflet being stretched was noted.The investigation found fibrous pannus ingrowth on the inflow surface of leaflets 1 and 2.There was calcification present on leaflet 3 and the leaflet was torn.There was no inflammation present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tear could not be conclusively determined; however, the calcification could have contributed to the tear formation.Also the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.Na.
Additional Manufacturer Narrative
An event of shortness of breath and explant due to severe aortic regurgitation was reported.It was also reported that there was pannus, incomplete coaptation, inflexible leaflets, and the left coronary cusp leaflet being stretched was noted.The investigation found fibrous pannus ingrowth on the inflow surface of leaflets 1 and 2.There was calcification present on leaflet 3 and the leaflet was torn.There was no inflammation present.The cause of the tear could not be conclusively determined; however, the calcification could have contributed to the tear formation.Also the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.H6 type of investigation: code 3331 removed.
Additional Manufacturer Narrative
An event of shortness of breath and explant due to severe aortic regurgitation was reported.It was also reported that there was pannus, incomplete coaptation, inflexible leaflets, and the left coronary cusp leaflet being stretched was noted.The investigation found fibrous pannus ingrowth on the inflow surface of leaflets 1 and 2.There was calcification present on leaflet 3 and the leaflet was torn.There was no inflammation present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.The cause of the tear could not be conclusively determined; however, the calcification could have contributed to the tear formation.Additionally the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• 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: 15997609
• Report Number: 2135147-2022-02626
• Device Sequence Number: 6655782
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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,Followup,Followup
• Report Date (Section B): 05/17/2023

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 Expiration Date: 02/18/2022
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 6351132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/26/2023; 01/30/2023; 04/21/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/26/2023; 01/30/2023; 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2018
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 43 KG