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

Catalog Number TFGT-23A

Device Problems Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/24/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2019, a 23mm trifecta gt valve was implanted.On (b)(6) 2022, the patient became aware of general fatigue and dyspnea on exertion.On (b)(6) 2023, a aortic regurgitation (ar) was diagnosed and hospitalized for heart failure.On (b)(6) 2023, a surgery was determined.On (b)(6) 2023, echocardiogram (echo) revealed a heart failure and it was due to tear of trifecta.The trifecta valve was explanted.A new 21mm epic supra was successfully implanted without any further adverse events or patient consequences.The patient was reported recovering.

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) 2019, a 23mm trifecta gt valve was implanted.In (b)(6) 2022, the patient became aware of general fatigue and dyspnea on exertion.In (b)(6) 2023, aortic regurgitation (ar) was diagnosed, and the patient was hospitalized for heart failure.On (b)(6) 2023, a surgery was scheduled.On (b)(6) 2023, echocardiogram (echo) revealed a heart failure, and it was due to tear of trifecta.The trifecta valve was explanted.A new 21mm epic supra was successfully implanted without any further adverse events or patient consequences.The patient was reported to be recovering.

Manufacturer Narrative

Explant of the device due to structural valve deterioration (svd) resulting in aortic regurgitation, symptoms of heart failure, general fatigue and dyspnea on exertion was reported.The investigation found that leaflets 2 and 3 were torn and there was fibrous thickening on leaflet 1.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.In the absence of any calcification or evidence of infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of svd, which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did not demonstrate loss of collagen at the tear sites and the cause of the leaflet tears could not be conclusively determined.

• Brand Name: TRIFECTA¿ GT 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: 18377873
• MDR Text Key: 331181631
• Report Number: 2135147-2023-05685
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• 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: 03/14/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6349557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 49 KG