According to initial reports, upon seating the valve, the leaflet was not functioning optimally.The surgeon tried rotating the valve with great difficulty, however the valve was, ultimately not used.
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According to initial reports, the valve leaflet was not functioning optimally.The surgeon tried rotating the valve with great difficulty, however the valve was not used.Additional information was received.The surgeon said he implanted the valve anti-anatomically as per company recommendations.The manufacturing records for the onxm-25 sn (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.An evaluation of the returned product was performed.The methods of observation performed were visual, microscopy, physical test.Prior to decontamination, visual examination of valve showed no obvious signs of damage.Both leaflets were freely moving.After decontamination, inspection of the part under the microscope showed no damage to the valve or leaflets.The sewing cuff shows evidence of use where sutures were possibly placed.The part was tested using a size 25 rotator.The rotator was easily able to rotate the part both clockwise and counter-clockwise with no resistance.The issue reported could not be replicated.The leaflets appear to be functioning as intended and the valve rotates freely.Root cause for this event is unknown.No additional actions are required.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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