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

Model Number TFGT-A

Device Problems Fracture (1260); Material Split, Cut or Torn (4008)

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

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported a patient underwent implant of a 19mm trifecta gt aortic valve on 13 (b)(6) 2017.During a follow up visit (date unknown) the patient presented with dyspnea and aortic regurgitation was identified.On (b)(6) 2022 the patient underwent explant of the trifecta valve.Upon removal, the stent post adhesion to the aorta is believed to have caused a crack from the r-n stent post.A tear was also observed on the valve leaflet.A non-abbott valve was implanted successfully.The patient remained stable throughout the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

Explant due to regurgitation and shortness of breath was reported.The investigation found that all three leaflets contained tears.There was also focal fibrous pannus on the outflow surface of leaflet 3.No acute inflammation, significant calcification, or stent deformation was found.Information from the field indicated that it was noted at explant that the valve had fused with the aorta the device history record was reviewed to ensure each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.This was inclusive of a review of the manufacturing videos, which contained no evidence of anomalies during functional inspection.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (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 site, and the cause of the leaflet tears could not be conclusively determined.However, at the time of valve explant there was evidence of fusion of a stent post to the aortic wall, which may be indicative of a narrow aortic sinus relative to the implanted valve size.A narrow aortic sinus may increase the interaction between the aortic wall and stent posts and has the potential to result in abrasion of the leaflet tissue along the stent post including the formation of pannus, which was noted on the explanted valve.The interaction between the stent posts and the aortic wall has the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, which in this case may have led to the observed leaflet tears and reduced durability.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.

• 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: 14655798
• MDR Text Key: 293733188
• Report Number: 2135147-2022-00361
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 5830722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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: 88 YR
• Patient Sex: Female