The returned valve prosthesis was received in general good conditions.The valve was inspected upon receival.No elements of not conformity according to the specifications or pre-existing defects were detected.A simulation of collapsing phases was performed in order to attempt to replicate the reported event, according to the indication included in the ifu (perceval ¿ sutureless aortic heart valve ¿ instructions for use ¿ ic0215001345 rev.J).For a complete investigation the simulation was performed with the returned valve and accessory kit.In addition, the collapsing simulation was repeated restoring the silicon cap of the returned holder in order to replicate the collapsing procedure with all the accessories having the correct configuration.The simulation of the valve collapsing, performed with the returned device and using the returned accessory kit (in both conditions as was and with the restored cap), was successfully completed according to the current procedure.No anomalous behaviors were observed during both the collapsing procedures.Based on the performed analysis, the reported issue is not related to factors intrinsic in the involved device (etq 2018-02462) or related accessories (etq 2018-02452).
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