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Catalog Number UNK AMPLATZER DUCT OCCLUDER |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Hemothorax (1896); Perforation (2001); Pleural Effusion (2010); Renal Failure (2041); Cardiac Tamponade (2226); Obstruction/Occlusion (2422)
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Event Date 01/01/2002 |
Event Type
Injury
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Manufacturer Narrative
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Summarized patient outcomes/complications of amplatzer duct occluder were reported in a research article in a subject population with multiple co-morbidities including hypertension, atrial fibrillation, diabetes, hyperlipidemia, prior percutaneous coronary intervention, prior coronary artery bypass graft, chronic kidney disease, heart failure, prior endocarditis, chronic pulmonary disease, prior reoperation, history of stroke, smoker, and hemolysis.Some of the peri- and post-procedural complications reported were stroke, acute kidney injury, pneumonia, cardiac tamponade, pleural effusion, effusion drainage (unexpected medical intervention), hemothorax, coronary obstruction, cardiac rupture, bleeding, endocarditis, rehospitalization, and reintervention (surgical intervention); 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.Based on the information received, the cause of the reported incident could not be conclusively determined.Literature attachment: article title "transcatheter closure or surgery for symptomatic paravalvular leaks: the multicenter kiss registry.
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Event Description
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The article, "transcatheter closure or surgery for symptomatic paravalvular leaks: the multicenter kiss registry", was reviewed.The article presented a retrospective, multicenter study to evaluate the long-term outcomes of the patients who underwent reoperation or transcatheter closure (tc) of paravalvular leaks (pvls).Devices included amplatzer vascular plug ii, amplatzer vascular plug iii, amplatzer vascular plug iv, amplatzer ductal occluder ii, amplatzer muscular ventricular septal occluder, amplatzer septal occluder, and occlutech.The article concluded that the current data suggest that percutaneous closure of pvl was associated with lower early and comparable long-term mortality rates compared with surgery.[the primary and corresponding author was (b)(6).The time frame of the study was from (b)(6) 2002 to (b)96) 2021.A total of 335 patients were included in the study, of which 93% received an abbott device.The average age was 58.15 years and the average gender was male.Comorbidities included hypertension, atrial fibrillation, diabetes, hyperlipidemia, prior percutaneous coronary intervention, prior coronary artery bypass graft, chronic kidney disease, heart failure, prior endocarditis, chronic pulmonary disease, prior reoperation, history of stroke, smoker, and hemolysis.
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Search Alerts/Recalls
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