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Catalog Number UNK EPIC STENTED PORCINE HV |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Inflammation (1932); Myocardial Infarction (1969); Cardiac Tamponade (2226); Coma (2417); Heart Block (4444)
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Event Date 01/01/2010 |
Event Type
Injury
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Event Description
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The article, "procedural selection strategy and clinical outcomes in mitral valve surgery with concomitant aortic valve replacement in elderly patients", was reviewed.The article presented a retrospective, single center study that investigated valve durability and survival using surgical strategy for mitral valve disease with concomitant surgical aortic valve replacement (savr) in elderly patients.Devices included in this study were magna ease, trifecta, mitroflow, mosaic, epic, physio ii, and memo 3d.The article concluded in double-valve surgery for elderly high-risk patients, appropriate selection of the mitral valve procedure with concomitant savr provided better early and long-term survival and valve durability.This surgical strategy may be beneficial in elderly patients with combined aortic and mitral valve disease.[the primary and corresponding author was kazuma handa, department of cardiovascular surgery, sakurabashi watanabe hospital, 2-4-32 umeda, kita-ku, osaka 530-0001, japan, with corresponding email: kazumahanda1116@gmail.Com].
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Manufacturer Narrative
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B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided summarized patient outcomes/complications of surgical valve implants were reported in a research article in a subject population with multiple co-morbidities.Some of the complications reported were bleeding, stroke, coma, dialysis (unexpected medical intervention), myocardial infarction, complete atrioventricular block, tamponade, gastrointestinal event, mediastinitis.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.Based on the available information, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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Search Alerts/Recalls
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