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

Catalog Number UNK TRIFECTA¿ GT VALVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Valvular Stenosis (2697); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 994 patients underwent aortic valve replacement between october 2011 and october 2020.Events of aortic stenosis and aortic regurgitation were reported; the trifecta valve had a 1.4% all-cause reintervention rate at 10 years, with insignificant impact on survival.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.

Event Description

The article "analysis of incidence and reasons for re-intervention after aortic valve replacement using the trifecta aortic bioprosthesis" was reviewed.This research article is a prospective multicentre experience to evaluate the perioperative patient and operative characteristics, and re-intervention rates and survival of patients undergoing surgical implantation of the trifecta and trifecta gt aortic bioprostheses in our center over a 10-year period.The trifecta and trifecta gt aortic bioprosthesis were involved in this study.The conclusion of this study was the trifecta valve had a 1.4% all-cause re-intervention rate at 10 years, with insignificant impact on survival.The primary author is [amir fard, md, university of glasgow, glasgow, uk, the corresponding author is [nawwar al-attar, professor, golden jubilee national hospital, agamemnon street, clydebank, g81 4dy, uk, nawwar.Alattar@gjnh.Scot.Nhs.Uk].

• 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: 14344736
• MDR Text Key: 291275905
• Report Number: 2135147-2022-00260
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK TRIFECTA¿ GT VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male