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

Catalog Number TF-23A

Device Problems Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2015, a 23mm trifecta valve was implanted during an aortic valve replacement.On (b)(6) 2023, the valve was noted to have stenosis and regurgitation due to valve leaflet stiffness.The valve was suspected to have structural valve deterioration (svd).The valve was explanted and replaced with a 23mm epic supra valve.The patient was later discharged.

Manufacturer Narrative

An event of stenosis and regurgitation due to valve leaflet stiffness was reported.It was reported that the valve was explanted due to suspicion of structural valve deterioration (svd).The investigation found circumferential fibrous pannus ingrowth with narrowing of inflow diameter.There was fibrous thickening on all leaflets.Calcifications present on leaflets 1 and 3.D.Leaflet 3 was torn with degenerative changes at the tear site.No acute inflammation was present.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the leaflet tear could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation.In addition, 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 tear and reduced durability.The calcifications noted could have contributed to the reported stenosis.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: 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: 18744170
• MDR Text Key: 335811358
• Report Number: 2135147-2024-00776
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: (01)05414734052030(17)260420(10)4681816
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TF-23A
• Device Lot Number: 4681816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male