The manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.The manufacturer was notified that no further information regarding the event is available.Because the device was not available for return and no further information is available no further investigations can be performed.As no information is available the root cause of the reported cardiac arrest cannot be determined at this time.As indicated in the initial report the valve was dislodged after cpr was performed on the patient.The instructions for use (ifu) for a perceval s valve states; after perceval s implantation, manipulation of the heart and/or of the ascending aorta, if required, should be done gently; should an atrial retractor be placed, take care not to compress the ascending aorta.These maneuvers may lead to unknown effects on the implanted valve, including displacement and folding.Patients with implanted perceval s valve may experience valve deformation when emergency cardiovascular procedures, such as cardiopulmonary resuscitation (cpr), are administered post implant.In such cases, an echocardiographic exam post-procedure is recommended, in order to verify the preserved position and function of the valve.This indicates that it is clearly outlined in the ifu that a known inherent risk of cpr is displacement of the valve.Based on the above analysis, and supporting information from the instructions for use, the adverse event cannot be attributed to factors intrinsic to the device in question.The root cause of the dislodgement is a result of the cpr, which is identified as a known inherent risk of procedure in the ifu.
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The manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.
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