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.Without return of the valve, a definitive root cause cannot be identified.
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Implant recovery cards received indicate that patient implanted with onxace-25 (4824304, valve 1) on (b)(6) 2015 indicated for aortic valve regurgitation and bacterial endocarditis.Re-intervention and explant required on (b)(6) 2015 for bacterial endocarditis, replaced with onxace-23 (4945312, valve 2).Additional re-intervention/explant required on (b)(6) 2015 indicated for "4+ aortic insufficiency with a rocking aortic valve suggesting dehiscence" and replaced with onxace-23 (3926503).This report is relegated to valve 1.
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