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

Catalog Number	TF-21A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2017, a 21mm trifecta valve was implanted during an aortic valve replacement.The native aortic annulus diameter was 25mm.On a later date, the patient presented with high gradient and shortness of breath.It was noted that the commissure between the left coronary cusp and the right coronary cusp had fused.Pannus was confirmed in subvalvular.Aortic stenosis was confirmed by transesophageal echocardiogram.On (b)(6) 2024, the valve was explanted.It was noted that the leaflets was possibly injured by the physician during explant due to handling with unprotected forceps/sharp instruments.However, no tear was observed in the leaflet or suture cuff.A 21mm non-abbott valve was implanted as a replacement.The patient was reported as stable.
Additional Manufacturer Narrative
Explant due to pannus, aortic valve stenosis, and dyspnea was reported.Information from the field indicated that the leaflets were possibly injured by the physician during explant due to handling with unprotected forceps/sharp instruments.The investigation found that there was a circumferential fibrous pannus ingrowth on the inflow surface of the valve with narrowing of the inflow diameter.All leaflets were observed to be torn.No acute inflammation or significant calcifications were present.Gross examination revealed cusp 1 had fibrous thickening with mildly limited mobility.There was a large piece of detached pannus from the inflow surface of leaflet 2 with chronic inflammation within it.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 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 dyspnea appears to be a cascading effect of aortic valve stenosis.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: 20102868
• Report Number: 2135147-2024-04295
• Device Sequence Number: 15563995
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)180609(10)BR00008023
• 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: 2017
• 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): 10/31/2024

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: 06/09/2018
• Device Catalogue Number: TF-21A
• Device Lot Number: BR00008023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2016
• 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; Hospitalization
• Patient Sex: Unknown