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

Catalog Number TFGT-21A

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

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

Event Date 01/03/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2017, a 21mm trifecta gt valve was successfully implanted.In (b)(6)2023, the patient visited a nearby facility due to difficulty breathing.On (b)(6) 2023, tear was observed in the stent area between the right coronary cusp and the non-coronary cusp.Severe aortic regurgitation was observed.On (b)(6) 2024, another procedure was performed.The trifecta was explanted and a 19mm valve was implanted.The patient is reported to be under rehabilitation.

Manufacturer Narrative

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

Manufacturer Narrative

Explant due to leaflet tear and severe aortic regurgitation was reported.The investigation found that leaflet 1 and leaflet 3 were torn.There was no acute inflammation or significant calcifications.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 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.The cause of the leaflet tear 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: 18711817
• MDR Text Key: 335527439
• Report Number: 2135147-2024-00677
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: (01)05415067018212(17)181027(10)5730968
• 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: 04/15/2024

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: 10/27/2018
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5730968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female