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)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/23/2024
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) 2017, a 19mm trifecta valve was implanted in a patient.On (b)(6) 2024, it was reported that a 19mm trifecta was explanted since the device has been torn, and was causing ar (aortic valve regurgitation), dyspnea, confirmed by echocardiograms.Upon explant, a tear was noted from the commissure between the left coronary cusp (lcc),and the right coronary cusp (rcc).There was also pannus noted on the valve.A 23mm epic plus suprawas implanted, and the procedure was completed.Patient condition is stable,.
Additional Manufacturer Narrative
Explant was reported due to device being torn, and was causing aortic valve regurgitation and dyspnea confirmed by echocardiograms.Upon explant a tear was noted from the commissure between the left coronary cusp and the right coronary cusp, and there was also pannus noted on the valve.The investigation found fibrous pannus ingrowth on inflow surface of leaflets 1 and 3.Leaflets 1 and 3 were torn.There were degenerative changes noted at tear site of leaflet 1.There were degenerative changes to the leaflet tissue including a denatured appearance to the collagen at leaflet 3.There was circumferential fibrous pannus formation on the sewing cuff.No acute inflammation or significant calcifications were present.The cause of the tears could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation.Additionally, 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 incomplete coaptation could have contributed to the reported regurgitation.

• 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: 19983825
• Report Number: 2135147-2024-03962
• Device Sequence Number: 4374900
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• 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
• 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): 10/28/2024

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: 03/31/2018
• Device Catalogue Number: TF-19A
• Device Lot Number: BR00006960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2016
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 60 KG