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.Paravalvular leak (pvl) and associated insufficiency are known, but relatively rare, complications of prosthetic valve implantation.In a 10-year experience at a single center, 428 on-x implants (264 aortic and 164 mitral) resulted in two cases of pvl, both considered minor and requiring no intervention [(b)(6) 2007].In a european multicenter study, out of 691 patients followed for a median of 5.5 years and up to 12.6 years, there were 4 observed late incidents of pvl in the aortic position, 12 in the mitral, and 4 double valve cases [(b)(6) 2013].In a usa multicenter study with 142 aortic and 142 mitral cases followed for a mean of 4.5 years, only one case of late pvl (in the aortic position) was observed and it was repaired on re-operation [(b)(6) 2006].Pvl can result from three primary conditions: necrosed annular tissue, most commonly due to endocarditis, dehiscence of the sewing cuff (that is, the stitching was compromised), or improperly seated at surgery.Aortic insufficiency and pvl are known potential complications 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 ((b)(4), 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 ((b)(4), 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 ((b)(4)).This report is relegated to valve 2.
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