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 Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/09/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Death date is estimated.
Event or Problem Description
It was reported that on (b)(6) 2019 a 19mm trifecta gt valve was successfully implanted.On an unknown date, aortic regurgitation was observed via echoaortography.The patient also experienced heart failure and dyspnea on exertion.On (b)(6) 2022, a non-emergency procedure was performed, and the trifecta gt valve was explanted.It was observed that the explanted trifecta gt valve had ruptured valve cusps.An unknown size non-abbott valve was implanted as a replacement.Medications were administered and the patient was placed on extracorporeal membrane oxygenation (ecmo).The following day on (b)(6) 2022, while the patient was on percutaneous cardiopulmonary support, the patient suddenly deteriorated and passed away.No additional information was provided.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Explant due to aortic regurgitation, heart failure and dyspnea on exertion was reported the investigation found all three leaflets were torn.There were degenerative changes noted at leaflet 1.No acute inflammation or significant calcifications were 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 degenerative changes noted to the tissue could have contributed to the tear formation.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 demonstrate denatured appearance to the collagen at the tear site, which could have contributed to the formation of the tear.
Event or Problem Description
It was reported that on (b)(6) 2019 a 19mm trifecta gt valve was successfully implanted.On an unknown date, aortic regurgitation was observed via echoaortography.The patient also experienced heart failure and dyspnea on exertion.On (b)(6) 2022, a non-emergency procedure was performed, and the trifecta gt valve was explanted.It was observed that the explanted trifecta gt valve had ruptured valve cusps.An unknown size non-abbott valve was implanted as a replacement.Medications were administered and the patient was placed on extracorporeal membrane oxygenation (ecmo).The following day on (b)(6) 2022, while the patient was on percutaneous cardiopulmonary support, the patient suddenly deteriorated and passed away.
Additional Manufacturer Narrative
An event of explant due to aortic regurgitation, heart failure and dyspnea on exertion and patient death were reported.The investigation found all three leaflets were torn.There were degenerative changes noted at leaflet 1.No acute inflammation or significant calcifications were present.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 demonstrate denatured appearance to the collagen at the tear site, which could have contributed to the formation of the tear.Nclt is characterized by thinning of the leaflet tissue with loss and disruption of collagen fibers at the tear site with absence of leaflet fibrosis and calcification.Nclt more commonly occurs within the first five (5) years post-implant and may occur due to implant-related technical factors such as valve oversizing and/or valve mishandling.Analysis of the returned device revealed disruption of collagen fibers at one of the tear sites with absence of leaflet fibrosis and calcification, consistent with nclt.An increase in operational leaflet stress due to valve oversizing or mishandling may have led to loss of collagen, however this could not be conclusively determined based on the information provided.As the size of the replacement valve was unknown, evidence of oversizing based on use of a smaller valve size at the time of replacement could not be determined.Based on visual inspection of the returned device, there is no apparent evidence of stent deformation.It is unknown whether there was any mishandling of the leaflet tissue at the time of implant that may have contributed to the observed leaflet tear.Therefore, no implant-related factors could be confirmed as information related to the implant procedure (e.G., operative notes, procedural imaging) was not provided from the site.The device history record was reviewed to ensure each manufacturing and inspection operation was performed, and the product met all specifications.Based on the totality of the information received, the cause of the reported incident could not be conclusively determined.The degenerative changes noted to the tissue could have contributed to the non-calcific leaflet tear formation.

• 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: 16109885
• Report Number: 2135147-2023-00059
• Device Sequence Number: 11273737
• 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: 2019
• 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
• Report Date (Section B): 05/02/2023

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: 09/23/2022
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 6688359
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 04/07/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/27/2023; 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2018
• 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: Death
• Patient Age: 82 YR
• Patient Sex: Female