ON-X LIFE TECHNOLOGIES, INC ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER - 19MM; MECHANICAL HEART VALVE
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Model Number ONXACE-19 |
Device Problem
Contamination (1120)
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Patient Problem
Endocarditis (1834)
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Event Date 08/14/2015 |
Event Type
Injury
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Manufacturer Narrative
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In 2016, on-x technologies incorporated (on-x) became a wholly owned subsidiary of cryolife, inc.(cryolife).A retrospective review of the on-x complaint system was performed to identify any areas requiring additional action and to appropriately assimilate the on-x process into the cryolife quality management system.In an abundance of caution this mdr is being reported to satisfy regulatory reporting obligations.Operated valve endocarditis is a recognized risk of prosthetic valves that could lead to thrombosis, thrombotic embolism, bleeding events, or paravalvular leak [akins 2008].The objective performance criteria of iso 5840 for rigid prosthetic valves indicates an endocarditis rate of 1.2 %/pt-yr.In the proact study for avr , there were 9 reported cases out of 375 implants [puskas 2014).Endocarditis of prosthesis is an infrequent, but known risk of aortic valve replacement using prosthetic heart valves.Endocarditis is a known potential complication listed in the instructions for use (ifu).Furthermore, this complication is not unique to the on-x device and is a risk associated with all mechanical heart valves.All observed risks are mitigated in the labeling and ifu.No further action required.
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Event Description
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Implant recovery cards received indicate that patient implanted with onxace-19 and onxm-25 on (b)(6) 2009 and required intervention/explant on (b)(6) 2014 with replacement via onxace-21 and onxm-27/29 indicated for aortic and mitral prosthetic valve endocarditis with ascending aortic aneurysm.This report is relegated to the onxace-19 valve.A separate report is being submitted for the other valve.
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Manufacturer Narrative
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Common device name corrected and udi added.(b)(4).Operated valve endocarditis is a recognized risk of prosthetic valves that could lead to thrombosis, thrombotic embolism, bleeding events, or paravalvular leak [akins 2008].The objective performance criteria of iso 5840 for rigid prosthetic valves indicates an endocarditis rate of 1.2 %/pt-yr.In the (b)(6) study for avr , there were 9 reported cases out of 375 implants [puskas 2014).Endocarditis of prosthesis is an infrequent, but known risk of aortic valve replacement using prosthetic heart valves.Endocarditis is a known potential complication listed in the instructions for use (ifu).Furthermore, this complication is not unique to the on-x device and is a risk associated with all mechanical heart valves.All observed risks are mitigated in the labeling and ifu.No further action required.
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Event Description
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Implant recovery cards received indicate that patient implanted with onxace-19 and onxm-25 on (b)(6) 2009 and required intervention/explant on (b)(6) 2014 with replacement via onxace-21 and onxm-27/29 indicated for aortic and mitral prosthetic valve endocarditis with ascending aortic aneurysm.This report is relegated to the onxace-19 valve.A separate report is being submitted for the other valve.
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