|
Catalog Number UNK EPIC STENTED PORCINE HV |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problems
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
Injury
|
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].
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|