The manufacturer was informed of the following event.On (b)(6) 2023, when implanting optiform prosthetic heart valve (f7-027), one leaflet was stuck and couldn't be opened.As such, the valve was explanted and another f7-027 was implanted in the patient to complete this procedure.Reportedly, patient was fine and stable.The test on the explanted valve was performed after explant and the leaflet had a stuck issue.Based on the further information received, thoracic surgery was performed to preserve the subvalvular structure.The subvalvular structure was observed and did not affect valve opening and closing, and the valve was also rotated.Reportedly, no additional debridement or reconstruction was performed before implanting the new valve.
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Valve was returned to the manufacturer for further investigation.After decontamination and cleaning a visual inspection was carried out without notice manufacturing defects.The sewing cuff was then removed, in order to identify the serial number, and its position, allowing a correct traceability of the valve and its components.The hydrodynamic testing was conducted on the cphv subassembly #29 of the valve f7-027 ¿ sn (b)(6).Since the target of the test was to evaluate the kinematic of the valve, it has been tested in aortic position, in order to have a better visibility of the leaflets movement.The test confirmed a normal leaflet kinematic showing a correct movement of the leaflets; no anomalies were observed during the open/close cycle of the pulsatile hydrodynamic test in both normotensive and hypotensive pressure conditions.Based on the analysis performed, the definitive root cause of the event cannot be established since no mechanical malfunction could be reproduced in our laboratories.Furthermore, from the document review performed, no manufacturing deficiencies were identified.Phenomena of partial leaflet immobilization, that could induce opening difficulty, have been described in the clinical literature to several models of mechanical valves.Possible causes from literature are entrapment between the leaflets and the housing of long suture tails, prosthesis size mismatch, suboptimal valve orientation and peculiar hydraulic conditions in the heart.For this specific case, considering that the valve finally implanted was the same model and size, it is possible to exclude the mis-sizing.Nevertheless, it is not possible to totally exclude that the conservative approach: ¿to preserve the sub-valvular structure¿ could have been the cause of leaflet entrapment and of the reported blocking behavior of the leaflet.
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