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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Unspecified Infection (1930); Myocardial Infarction (1969); Pleural Effusion (2010); Pericardial Effusion (3271); Heart Block (4444)

Event Date 01/01/2017

Event Type  Death  

Manufacturer Narrative

Literature article: an analysis of early results after valve replacement in isolated aortic valve stenosis by using sutureless vs.Stented bioprostheses: a single-center middle-income country experience.Summarized patient outcomes/complications of an analysis of early results after valve replacement in isolated aortic valve stenosis by using sutureless vs.Stented bioprostheses: a single-center middle-income country experience were reported in a research article in a subject population with multiple co-morbidities including diabetes mellitus, hypertension, peripheral vascular disease, chronic kidney disease, prior stroke, smoking, aortic stenosis (angina, dyspnea, syncope).Some of the complications reported were death, infection, pleural effusion, pericardial effusion, stroke, atrial fibrillation, heart block, pacemaker implant (surgical intervention), myocardial infarction, bacterial endocarditis of prosthesis, arrhythmia, valve reoperation (re-hospitalization) these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

Event Description

The article, ¿an analysis of early results after valve replacement in isolated aortic valve stenosis by using sutureless vs.Stented bioprostheses: a single-center middle-income country experience¿, was reviewed.The article presented a retrospective single center experience to compare the survival of people with isolated severe aortic stenosis after the implantation of sutureless and stented bioprostheses in a tertiary referral center in serbia.Devices included in this study were st jude epic, st jude trifecta, sorin crown, and perceval.The article concluded that predictors of all-cause mortality over a median of 2 years of follow-up were older age, having a higher preoperative euroscore ii, having a stroke over the follow-up and having valve-related complications.Survival after bioprostheses implantation should be monitored long-term to ensure optimum postoperative outcomes.[the primary author was marko kaitovic, cardiac surgery department, institute for cardiovascular diseases ¿dedinje¿, 11040 belgrade, serbia.The corresponding author was tatjana gazibara, institute of epidemiology, faculty of medicine, university of belgrade, 11000 belgrade, serbia, with corresponding email: tatjana.Gazibara@med.Bg.Ac.Rs].The time frame of the study was from 2017 to 1 july 2021.A total of 339 patients were included in this study, of which 183 patients received an epic valve and 10 received a trifecta valve (total % = 67.3%).The average age was 72.5 years (stented bioprosthesis=72.8, sutureless=72.1) and average age was gender was male (stented bioprosthesis=150, sutureless=33).Comorbidities included were diabetes mellitus, hypertension, peripheral vascular disease, chronic kidney disease, prior stroke, smoking, aortic stenosis (angina, dyspnea, syncope).

• Brand Name: SJM TRIFECTA 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: 17647277
• MDR Text Key: 322240542
• Report Number: 2135147-2023-03759
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SJM TRIFECTA VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• 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): Hospitalization; Life Threatening; Death; Required Intervention; Disability