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

Model Number TF-21A

Device Problem Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2013, a 21 trifecta valve was successfully implanted.On (b)(6) 2023, the patient presented to the hospital with shortness of breath.It was confirmed that the patient had experienced bilateral pleural effusion.On (b)(6) 2023, the patient was hospitalized due to severe aortic regurgitation.On (b)(6) 2023, the trifecta valve was explanted, and an unknown size non-abbott valve was implanted as a replacement.Post explant, there was no calcification or other visible valve failures.No additional information was provided.

Manufacturer Narrative

Explant due to severe aortic regurgitation was reported.The investigation found there was fibrous thickening on all leaflets.All three leaflets were torn.There was fibrous pannus ingrowth on the inflow surfaces of leaflets 1 and 3 and on the outflow surface of leaflet 3.There were degenerative changes on leaflets 2 and 3.Micro-calcification was present on leaflet 3.No inflammation was 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 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.Additionally, the degenerative changes noted to the tissue could have contributed to the tear formation.

• 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 #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: 16390351
• MDR Text Key: 309732433
• Report Number: 2135147-2023-00556
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2014
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3704299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2012
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 65 KG