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

Catalog Number	TF-19A
Medical Device Problem Codes	Calcified (1077); Material Puncture/Hole (1504); Patient-Device Incompatibility (2682); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/25/2024
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) 2014, a 19mm trifecta valve was implanted during an aortic valve replacement.The native aortic valve annulus was measured as 25mm.On (b)(6) 2024, the patient presented with symptoms of heart failure, including shortness of breath and palpitations.An echocardiogram revealed aortic regurgitation.On (b)(6) 2024, the valve was explanted, and a hole was found in the non-coronary cusp (ncc) of the valve.It was observed that there was a suture near the area, and it was believed that this suture adhered to the ncc, causing the hole.Pannus and calcification was also noted on the valve.A 23mm epic plus valve was implanted.The patient was reported as stable.
Additional Manufacturer Narrative
Explant due to heart failure, including shortness of breath, aortic valve insufficiency and torn cusp was reported.The device was returned to abbott for analysis and the investigation found that the sewing cuff was observed to be torn.Cusp 2 was observed to be torn.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 reported aortic valve insufficiency to be related to the patient condition (pannus formation).However, the cause of the pannus formation could not be conclusively determined.The cause of the tear could not be conclusively determined; however, 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.The reported hospitalization and surgical intervention were a result of case-specific circumstances as the valve was explanted and a replacement valve was implanted.Per the information available abbott cannot further speculate on why the reported event occurred.
Event or Problem Description
It was reported that on (b)(6) 2014, a 19mm trifecta valve was implanted during an aortic valve replacement.The native aortic valve annulus was measured as 25mm.On (b)(6) 2024, the patient presented with symptoms of heart failure, including shortness of breath and palpitations.An echocardiogram revealed aortic regurgitation.On (b)(6) 2024, the valve was explanted, and a hole was found in the non-coronary cusp (ncc) of the valve.It was observed that there was a suture near the area, and it was believed that this suture adhered to the ncc, causing the hole.Pannus and calcification was also noted on the valve.A 23mm epic plus valve was implanted.The patient was reported as stable.

• Brand Name: TRIFECTA¿
• 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 LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20759464
• Report Number: 2135147-2024-05941
• Device Sequence Number: 9282937
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: (01)05414734052016(17)140820(10)3845544
• 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: 2014
• 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): 02/06/2025

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: 08/20/2014
• Device Catalogue Number: TF-19A
• Device Lot Number: 3845544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2012
• 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: 83 YR
• Patient Sex: Male