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

Model Number TFGT-A

Device Problem Perivalvular Leak (1457)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 03/22/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 21mm trifecta gt valve was implanted in a patient.It was confirmed via transesophageal echocardiography (tee) that the patient had a perivalvular leak (pvl) associated with the device.The patient underwent emergency surgery to have the device explanted and replaced with a 21mm non-abbott device.It was reported there was a clinically significant delay in the procedure due to this event.It was reported the patient experienced high blood pressure associated with this event and was readmitted to the hospital post-procedure for recovery.

Manufacturer Narrative

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

Manufacturer Narrative

An event of paravalular leak and high blood pressure after implant was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that on (b)(6) 2023, a 21mm trifecta gt valve was implanted in a patient.It was confirmed via transesophageal echocardiography (tee) that the patient had a perivalvular leak (pvl) associated with the device.The patient underwent emergency surgery to have the device explanted and replaced with a 21mm non-abbott device.It was reported there was a clinically significant delay in the procedure due to this event.It was reported the patient experienced high blood pressure associated with this event and was readmitted to the hospital post-procedure for recovery.

• 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: 16727384
• MDR Text Key: 313189932
• Report Number: 2135147-2023-01595
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2023
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 7228705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• 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; Life Threatening; Required Intervention