The manufacturing and material records for the perceval heart valve, model #icv1211 , s/n # a96362, 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 #icv1211) perceval heart valve at the time of manufacture and release.Since the device disposition after the procedure is reportedly unknown and, ultimately, was not returned to the manufacturer, no further device investigation is possible at this time.Based on the information available, it is not possible to establish a definitive root cause for the reported event.Considering the information reported identifying no device malfunctions but "device rocking" identified at the tee post-implant, possible factors that may have contributed to the event include a device undersizing, device malpositioning or patient's related factors (i.E.Bulky calcium) which prevented a proper anchoring of the valve at the annulus level.Ultimately, since no details on the procedure was provided and no further investigation on the device was possible, the root cause remains unknown at this time.
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The manufacturer received information on this event through the patient tracking department.Based on the information reported in the patient registration form, on (b)(6) 2020, a patient was intended to receive a perceval pvsxl in aortic position.The device was reportedly explanted intraoperatively.Additional information received from the hospital confirmed that the valve was explanted due to valve rocking on post-implant tee.The perceval xl valve was replaced by a 27 mm st.Jude trifecta tissue valve.No device malfunctions were identified, and the patient had an excellent outcome after the procedure.The device disposition after the explant is unknown.During the same procedure, the following concomitant procedures were performed: bi-atrial cox-4 maze, and laa clip.The patient underwent aortic valve replacement due to severe aortic stenosis.
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