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

Catalog Number UNK TRIFECTA¿ GT VALVE

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888)

Event Date 01/01/2009

Event Type  Injury  

Event Description

The research article "mechanical versus biological valve prostheses for left-sided infective endocarditis" was reviewed.This research article is a retrospective single center cohort study with the goal to analyze the outcomes after implantation of mechanical versus biological valve prostheses in patients presenting with left-sided infective endocarditis.The devices associated with this study were abbott masters, medtronic mechanical, cryolife on-x aortic, edwards magna ease, medtronic freestyle, cryolife on-x mitral, medtronic mosaic mitral.The conclusion of this study was that in patients presenting with left-sided infective endocarditis <55years of age, implantation of a mechanical valve prosthesis is associated with superior outcomes.[primary author: amila kahrovic, dept of cardiac surgery, medical university of vienna, vienna, austria, with corresponding author philipp angleitner , email: philipp.Angleitner@medniwien.Ac.At].

Manufacturer Narrative

As reported in a research article, 220 patients underwent valve replacement surgery due to endocarditis between january 2009 and december 2018; the devices associated with this study were abbott masters, medtronic mechanical, cryolife on-x aortic, edwards magna ease, medtronic freestyle, cryolife on-x mitral, medtronic mosaic mitral.Events of prosthetic valve endocarditis, prolonged ventilation, prolonged hospitalization, atrial fibrillation, ischemic stroke, intracranial bleeding, and valve related re-operation were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device or additional patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.For mdr purposes only: the date of occurrence is estimated as range of dates when the study/registry took place, for reportability purposes.(01 jan 2009 through 01 dec 2018).Related manufacturer reference number: 2135147-2022-00279-00, 2135147-2022-00280-00.

• 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: 14416250
• MDR Text Key: 291825971
• Report Number: 2135147-2022-00281
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TRIFECTA¿ GT VALVE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male