The manufacturer received information on a patient, implanted with a crown prt valve, model cna21, on (b)(6) 2020 that was re-admitted to the hospital on (b)(6) with heart failure/aortic regurgitation.The transthoracic echocardiogram (toe) showed a leaflet dysfunction.Specifically, it was reported that there appears to be restricted motion of one of the valve cusps.There was no thrombus/pannus identified as root cause of the stuck leaflet.The patient was treated with valve in valve (tavi) on (b)(6) 2020 and the patient received 23mm medtronic evolut pro.As reported, in theatre on the toe that one leaflet was a bit strange but was mild aortic regurgitation at the time.
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The manufacturing and material records for the crown prt aortic pericardial heart valve, model#: cna21, s/n#: (b)(6) , as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.A review of the function test (open/close valve) at the time of manufacture and release was also perform.The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.The manufacturer attempted to retrieve additional information on the event, but no further details has been received to date.Since the device was not explanted, no further investigation is possible at this time.Based on the information available, it is not possible to draw a definitive conclusion on the reported event.However, per the document review performed, no manufacturing deficits have been identified.Should further information become available in the future, the manufacturer will provide an update to this reporting activity.
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