A review of the available information was performed.A copy of the intra-operative echos were provided and reviewed.It was noted that there was significant anterior leakage and that the presence of anterior paravalvular leak (pvl) could not be confirmed or denied.It was confirmed that the leak was not due to on-x valve signature washing jets.A definitive determination for the type or cause of the leak cannot be made.Regardless, a leak of some type was present and explant of the valve was required and reimplantation was performed.The instructions for use for the on-x valve acknowledge paravalvular leak as a potential complication following prosthetic valve replacement, which may lead to reoperation as well as explanation [ifu].Historically, pvl occurs at a rate 1.2% per patient-year for all pvls, while major pvl occurs at a rate of 0.6% per patient-year for rigid heart valve substitutes [iso 5840:2005(e)].The manufacturing records for the packaging of valve onxae-27/29 serial number (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The valve was returned for evaluation.Valve was received as an intact valve assembly.Prior to decontamination visual examination of valve shows leaflet and housing intact.No tissue or thrombus evident.Leaflets fully open & close without bind.After decontamination, no evidence of visual anomalies in pivot location or on leaflets as assembled.Valve was disassembled & components were dimensionally inspected.The valve housing & leaflets were reassembled, functionally, & visually inspected.Valve passed dimensional, functional, & visual inspections.No deficiencies noted regarding this valve.This event does not identify additional hazards or modify the probability and severity of existing hazards.No further action is required at this time.Should additional information become available, it will be evaluated and the complaint will be reopened.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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