Catalog Number UNK AMPLATZER PFO OCCLUDER |
Device Problems
Migration or Expulsion of Device (1395); Off-Label Use (1494)
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Patient Problems
Atrial Fibrillation (1729); Erosion (1750); Stroke/CVA (1770); Fever (1858); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Perforation (2001); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422); Pericardial Effusion (3271); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)
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Event Date 01/01/1999 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature: article titled "outcome of transcatheter atrial septal defect closure in a nationwide cohort".
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Event Description
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The article, "outcome of transcatheter atrial septal defect closure in a nationwide cohort", was reviewed.The article presented a retrospective, multicenter study to evaluate the long-term outcome of transcatheter-closed atrial septal defects (asds).The devices included in this study were amplatzer asd occluder, amplatzer cribriform occluder, amplatzer pfo occluder, figulla, helex, and starflex.The article concluded that after transcatheter (tc) closure of asd, patients had a higher risk of new-onset atrial fibrillation and migraine than controls without asd.As novel findings, they found an increased risk for ischemic heart disease, atrioventricular (av) conduction disorders, and ventricular fibrillation/tachycardia.[the primary and corresponding author was valterri muroke, department of cardiology, heart and lung center hus, helsinki university hospital, pl 340, 00029 hus, helsinki, finland, with corresponding email: valtteri.Muroke@helsinki.Fi] the time frame of the study was rom 1999 to 2019.A total of 1000 patients were included in this study, of which 89.9% received an abbott device.The average age was 37.9 years, and the average gender was female.Comorbidities included concomitant congenital heart defect, atrial septal defect, atrial fibrillation, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, migraine, stroke, transient ischemic attack, floppy septum, multi-fenestrated atrial septal defect.
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Manufacturer Narrative
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Summarized patient outcomes/complications of amplatzer pfo occluder were reported in a research article in a subject population with multiple co-morbidities including concomitant congenital heart defect, atrial septal defect, atrial fibrillation, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, migraine, stroke, transient ischemic attack, floppy septum and multi-fenestrated atrial septal defect.Some of the complications reported were embolization, bleeding, erosion, ruptured septum (perforation), coronary occlusion, pericardial effusion, fever, allergic reaction, pneumonia, stroke, heart failure, atrial fibrillation, ventricular fibrillation, heart block, pacemaker implant (surgical intervention) and hospitalization.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.Please note that per the instructions for use, "the amplatzer¿ pfo occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (pfo) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke." literature attachment: article title "outcome of transcatheter atrial septal defect closure in a nationwide cohort".
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Search Alerts/Recalls
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