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

Model Number	TFGT-A
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/12/2023
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 25mm trifecta gt valve was successfully implanted in the patient's native aorta.On an unknown date in 2020, aortic regurgitation (ar) was observed via transthoracic echocardiogram (tte).The patient did not present with symptoms of heart failure.A follow-up was performed, and the patient's left ventricular diastolic dysfunction (lvdd) exceeded 65mm.On (b)(6) 2023, a tear was observed on the trifecta valve, it was explanted, and a 21mm sjm masters series mechanical heart valve was implanted as a replacement.A portion of the stent post was cut during extraction.The explanted trifecta valve was analyzed, and the left coronary cusp and non-coronary cusp stent posts were torn.No pannus or calcification was observed on the explanted valve.
Additional Manufacturer Narrative
Explant of the device due to regurgitation and left ventricular diastolic dysfunction was reported.The device was received for investigation and all three leaflets were removed from the valve stent.In addition, one valve stent post was cut off, which was reported to be due to the explant procedure.No inflammation, calcifications, or thinning of the leaflet tissue was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the exact cause of the tear could not be conclusively determined, no thinning was noted in the leaflet tissue sectioned, giving no etiology for the reported tear.The tear reported could have caused the regurgitation reported.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17269047
• Report Number: 2135147-2023-02913
• Device Sequence Number: 18134364
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: 05415067018236
• 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: 2023
• 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): 08/17/2023

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: 09/12/2021
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 6155266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2017
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male