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

Catalog Number TFGT-23A

Device Problem Incomplete Coaptation (2507)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 23mm trifecta gt was selected for an implant.Once the trifecta valve was implanted, the physician spread normal saline on the trifecta valve for function test, and found it was not working.For safety, the physician explanted the trifecta valve and exchanged to non-abbott device.Patient is well treated and stable.

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) 2023, a 23mm trifecta gt was selected for an implant.Once the trifecta valve was implanted, the physician spread normal saline on the trifecta valve for function test, and found it was not working.For safety, the physician explanted the trifecta valve and exchanged to non-abbott device.Patient is well treated and stable.

Manufacturer Narrative

The reported event of valve cannot coapt well could not be confirmed.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.The free state of the leaflets, without physiological pressure applied, is not indicative of actual leaflet coaptation or valve function.Imaging from the field appeared to show the placement of the valve.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 reported event 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: 17725884
• MDR Text Key: 323158008
• Report Number: 2135147-2023-03943
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 7715145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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): Required Intervention