ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER II, ADDITIONAL SIZES; OCCLUDER, PATENT DUCTUS, ARTERIOSUS
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Catalog Number UNK AMPLATZER DUCT OCCL II, AS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/01/2016 |
Event Type
Death
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Event Description
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The article, ¿percutaneous closure of the patent ductus arteriosus in infants #2 kg: impact registry insights¿, was reviewed.The article presents a retrospective, multicenter experience to assess safety and feasibility of percutaneous pda closure in patients #2 kg.Devices included in this study are amplatzer piccolo occluder, medtronic microvascular plug, amplatzer ductal occluder ii, and amplatzer vascular plug ii.The article concluded percutaneous pda closure appears to be safe and feasible procedures in infants #2 kg.The incidence of major adverse events has continued to decline over the years and seems to have a strong correlation with individual center case volumes and expertise.[(b)(6).] the time frame of the study was from april 2016 through june 2021.A total of 1587 patients were included.The average age and weight at intervention was 37 days and 1.2kg and the average gender was male.Comorbidities included necrotizing enterocolitis, sepsis, and genetic/chromosomal syndrome.
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Manufacturer Narrative
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Literature article: percutaneous closure of the patent ductus arteriosus in infants #2 kg: impact registry insights b2 - date of death is estimated.B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided the additional patient effects and malfunctions reported in the articles are captured under separate medwatch reports.Summarized patient outcomes/complications of closure of patent ductus arteriosus defects with occlusion devices including amplatzer duct occluder ii additional sizes were reported in a research article in a subject population with multiple co-morbidities including necrotizing enterocolitis, sepsis, and genetic/chromosomal syndrome.Some of the complications reported were device embolization, unplanned cardiac or vascular surgery, cardiac arrest, cardiac tamponade, device malposition, thrombus, arrhythmia, bleeding, airway escalation of care 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.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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