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

Catalog Number	TF-19A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/02/2024
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) 2015, a 19mm trifecta valve was implanted during an aortic valve replacement.On (b)(6) 2024, structural valve deterioration (svd) and leaflet tear were confirmed by echocardiography.On (b)(6) 2024, the valve was explanted.The valve had stenosis, regurgitation, pannus, and svd.The valve was replaced with a 17mm sjm regent heart valve with flex cuff.The patient status was reported as stable.
Additional Manufacturer Narrative
Explant due to aortic valve stenosis, aortic valve insufficiency, pannus, and torn cusp was reported.The device was returned to abbott for analysis and the investigation found that all cusps were observed to be torn and had fibrous thickening.The inflow surface of cusp 3 had fibrous pannus ingrowth limited to the sewing cuff.The sewing cuff 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 stenosis appears 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.
Event or Problem Description
N/a.

• 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: 20368388
• Report Number: 2135147-2024-04875
• Device Sequence Number: 3689666
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: (01)05414734052016(17)161027(10)5013184
• 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: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2024

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: 10/27/2016
• Device Catalogue Number: TF-19A
• Device Lot Number: 5013184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2014
• 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: 50 YR
• Patient Sex: Unknown
• Patient Weight: 51 KG