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Model Number ONXAAP-25 |
Device Problem
Contamination (1120)
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Patient Problem
Endocarditis (1834)
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Event Date 01/07/2014 |
Event Type
Injury
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Manufacturer Narrative
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(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 onxm-25 valve.A separate report is being submitted for the other valve.
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Manufacturer Narrative
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Note: the initial report for 1649833-2016-00016 submitted 09/16/2016 contained information for the wrong product and was updated in this follow-up report.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 onxaap-25 on (b)(6) 2013 and required intervention/explant on (b)(6) 2014 and replacement with another onxaap-25 indicated for prostatic valve endocarditis with (b)(6), subvalvular aortic vegetation, and infected ascending aorta and hemiarch graft.Procedures performed were redo sternotomy, redo aortic root replacement with a 25-mm on-x mechanical valve conduit, redo ascending aorta and hemiarch repair with 26-mm hernashield graft, modified cabral with saphenous vein graft to right coronary ostium, endoscopic saphenous vein harvest, and placement of 2-catheter marcaine infusion pump.
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Manufacturer Narrative
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Note: the initial report for 1649833-2016-00016 submitted 09/16/2016 contained information for the wrong product and was updated in this follow-up report.Note 2: udi added.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 (b)(4).In the (b)(4) study for avr , there were (b)(4) reported cases out of (b)(4) 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 onxaap-25 on (b)(6)2013 and required intervention/explant on (b)(6) 2014 and replacement with another onxaap-25 indicated for prostatic valve endocarditis with (b)(6), subvalvular aortic vegetation, and infected ascending aorta and hemiarch graft.Procedures performed were redo sternotomy, redo aortic root replacement with a 25-mm on-x mechanical valve conduit, redo ascending aorta and hemiarch repair with 26-mm hernashield graft, modified cabral with saphenous vein graft to right coronary ostium, endoscopic saphenous vein harvest, and placement of 2-catheter marcaine infusion pump.
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Search Alerts/Recalls
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