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

Model Number TFGT-A

Device Problems Calcified (1077); Incomplete Coaptation (2507); Material Split, Cut or Torn (4008); Central Regurgitation (4068)

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

Event Date 01/30/2023

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) 2018, a 25mm trifecta valve was successfully implanted.About 4 years later, the patient reported shortness of breath.In a scheduled appointment, it was determined that the patient had aortic insufficiency.On (b)(6) 2022, the device was explanted, and an unknown size epic plus valve was implanted as a replacement.There were leaflet tears and calcification on the explanted valve.The trifecta valve also showed incomplete coaptation after explant.The patient was reported as discharged.No additional information was provided.

Manufacturer Narrative

Explant due to shortness of breath and aortic insufficiency was reported.The investigation found that all leaflets contained calcifications.Leaflets 2 and 3 were found torn.Leaflets 1 and 3 were found to have previous incisions.There was fibrous pannus ingrowth on the inflow surface of leaflet 1 and fibrous thickening on all leaflets.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 tears could not be conclusively determined; however, the fibrous pannus ingrowth and calcifications 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.

• 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: 16417742
• MDR Text Key: 309976310
• Report Number: 2135147-2023-00628
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: 05415067018236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2022
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 6653480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2018
• 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: 78 YR
• Patient Sex: Male