|
Catalog Number UNK SJM TRIFECTA VALVE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/01/2016 |
Event Type
Death
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "thrombocytopenia among patients undergoing aortic valve replacement using the sutureless perceval s bioprosthesis.".
|
|
Event Description
|
The article "thrombocytopenia among patients undergoing aortic valve replacement using the sutureless perceval s bioprosthesis" was reviewed.The article presented a restrospective single center study, to compare the incidence, severity, and clinical implications of thrombocytopenia after aortic valve replacement (avr) using the perceval s or the trifecta bioprosthesis.Abbott devices used included the trifecta aortic valve.The article concluded that the perceval s bioprosthesis was associated with more severe postoperative thrombocytopenia.[the primary author and corresponding author was matthias kirschwith corresponding email matthias.Kirsch@chuv.Ch.The time frame of the study was march 2016 to august 2019.A total of 156 patients were included in this study, of which 53 received an abbott device.Comorbidities include previous myocardial infarction, congestive heart failure, diabetes, hypertension, hypercholesterolemia, chronic obstructive pulmonary disease, cerebrovascular arteriopathy, lower extremity arterial disease, previous valve replacement, aortic regurgitation, and bicuspid aortic valve.
|
|
Manufacturer Narrative
|
Summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with multiple co-morbidities including previous myocardial infarction, congestive heart failure, diabetes, hypertension, hypercholesterolemia, chronic obstructive pulmonary disease, cerebrovascular arteriopathy, lower extremity arterial disease, previous valve replacement, aortic regurgitation, and bicuspid aortic valve.Some of the complications reported were thrombocytopenia, atrial fibrillation, surgical intervention, postoperative stroke and death.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.Literature attachment: article title "thrombocytopenia among patients undergoing aortic valve replacement using the sutureless perceval s bioprosthesis: a retrospective study".The additional patient effects reported in the article are captured under separate medwatch report.
|
|
Search Alerts/Recalls
|
|
|