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

Catalog Number TFGT-23A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/09/2023

Event Type  Death  

Event Description

The article, "new challenges for the surgeon in the modern era of transcatheter aortic valves: early single center experience of their surgical explantation", was reviewed.The article presented a case study of a 66-year-old male with prior transcatheter valve replacement and prior prosthetic endocarditis with aortomitral abscess.It was reported that on an unknown date, a 23mm trifecta valve was chosen for aortic valve implant along with a concomitant 29mm edwards perimount valve for mitral valve.It was reported 41 days post-procedure, the patient passed away in the referral hospital due to sepsis with subsequent multiple organ failure.The article concluded long-term durability of transcatheter heart prostheses compared to their surgically implanted counterparts has not been yet established.As long as their different failure modes are not entirely clarified, further long-term clinical and echocardiographic follow-up are required.Initial experience shows that a failing tavi-implant may be conventionally surgically replaced without an excessive operative risk.[the primary and corresponding author was kyriakos spiliopoulos, department of thoracic and cardiovascular surgery, university of (b)(6) greece, with corresponding email: (b)(6)].

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title: new challenges for the surgeon in the modern era of transcatheter aortic valves: early single center experience of their surgical explantation.

Manufacturer Narrative

As reported in a research article, new challenges for the surgeon in the modern era of transcatheter aortic valves: early single center experience of their surgical explantation.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.From medical review: the cause of death is related to the endocarditis and on-going infection progressing to sepsis.

• 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: 17878305
• MDR Text Key: 325011290
• Report Number: 2135147-2023-04340
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: TFGT-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 66 YR
• Patient Sex: Male